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

Model Number	M006180155090
Medical Device Problem Codes	Break (1069); Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/23/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 to be removed in a ureteroscopy procedure performed on (b)(6) 2018.The stent was reported to have been implanted two months prior to this date.When removal was started, the right side of the stent was lifted with a grasper, and snapped.The fragments were unable to be retrieved.The second attempt was made in removing the stent, and difficulty was encountered, another small piece of the stent snapped.The ureteroscope was not able to progress beyond the broken stent bits.The stent was also noticed to be encrusted.It was lasered until it was free of stone.The fragments were retrieved, and the ureter was reported to be intact.The stent pieces that broke off were unable to be retrieved and were left to pass naturally.Further retrograde was required, and another contour vl¿ stent was implanted for a two week duration.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be "good".

• 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: 7272641
• Report Number: 3005099803-2018-00389
• Device Sequence Number: 13494020
• Product Code: FAD
• UDI-Device Identifier: 08714729423768
• UDI-Public: 08714729423768
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/24/2018

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 Model Number: M006180155090
• Device Catalogue Number: 180-155-09
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/15/2018
• 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