The patient's right kidney was not functioning due to the presence of a staghorn calculus and was reported to be unrelated to the event in the left ureter. On b 6 the patient was reported to be doing "fine". It was reported to boston scientific corporation that an escape nitinol stone retrieval basket was used in a cysto ureteroscopy procedure with laser and basket stone retrieval in the patient's left ureter on b 6 On b 6 the patient was reported to be doing "fine.
Was: adverse event, changed to: reported issue is both an adverse event and a product problem. Changed to: required intervention. On b 6 , the patient was reported to be doing "fine. Analysis of the returned escape nitinol retrieval basket fragment revealed the basket was cut. The distal end of the wire sub-assembly was returned. The basket was bent, and the proximal end of the fragment was bent and appeared to be cut.
According to the complainant, observation by a distribution warehouse employee revealed that the proximal end of the device stem exhibited a rust like stain. No visible damage was noted on the packaging and the package seal was intact. Reportedly, the device was received b 6 , , removed from the outer box and stored on a shelf in an air conditioned, temperature and humidity controlled room.
There is no patient or procedure information available as this device was never shipped to a customer. The returned device indicated that the filaform tip of the segura retrieval basket was slightly discolored. The product was determined to have met biocompatibility requirements and the apparent discoloration is cosmetically acceptable per bsc procedures.
This discoloration does not pose a risk to patients, therefore, the most probable root cause for the complaint is user preference. Upon further review of all available information this event is considered a non reportable event.
Promotes secure grasp of calculi and small stone fragments. It's designed to open and retain its helical shape within the ureter.
The LithoVue Empower Device, a physician-controlled retrieval device, puts the critical task of stone removal in the hands of the surgeon. The precision basket that puts you in control. Now you can approach and capture fragments with a flexible basket that gives you the precision and control you need in tight places. With a small 1.
The RescueNet Device is specifically designed for optimal visibility, control and strength for quick and efficient foreign body removal.
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