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

Model Number	M0061801550
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device cannot be completed.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 in a stent placement procedure performed in the kidney, ureter and bladder on (b)(6) 2018.According to the complainant, during procedure, the physician noticed that there were tiny fragments shearing off of the stent and into the patient, while removing it from the wire.The procedure was completed with another contour vl¿ stent.Due to the size of the fragments, the fragments were left to pass on their own with no plans for removal at a later date.The patients¿ condition at the conclusion of the procedure was reported to be stable.

• 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: 7423388
• Report Number: 3005099803-2018-01170
• Device Sequence Number: 786024
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K974541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/17/2020
• Device Model Number: M0061801550
• Device Catalogue Number: 180-155
• Device Lot Number: 21526389
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR