MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) CONTOUR VL¿; STENT, URETERAL

Model Number	M0061801570
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl¿ stent was used during ureteroscopy procedure performed in the kidney, ureter and bladder on (b)(6) 2017.According to the complainant, while the physician was advancing the contour vl stent over the guidewire, the stent became accordion and the guidewire ripped the side of the stent.The stent coil detached near the last marker, and the detached piece was removed using a stent grasper.The procedure was completed with a different device.There were no reported issue at the conclusion of the procedure.

• Brand Name: CONTOUR VL¿
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6915322
• Report Number: 3005099803-2017-03008
• Device Sequence Number: 19160522
• Product Code: FAD
• UDI-Device Identifier: 08714729068020
• UDI-Public: 08714729068020
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2020
• Device Model Number: M0061801570
• Device Catalogue Number: 180-157
• Device Lot Number: 20702323
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2017
• Initial Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention