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

Model Number M0061801550

Device Problem Material Frayed (1262)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/20/2018

Event Type  malfunction  

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 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¿
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7423388
• MDR Text Key: 105517457
• Report Number: 3005099803-2018-01170
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 08714729058410
• UDI-Public: 08714729058410
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K974541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2018
• Initial Date FDA Received: 04/11/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/18/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR