MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR VL; STENT, URETERAL

Model Number	M0061801570
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl stent was sed during a stone removal and insertion of jj stent procedure, performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken into two along shaft.The procedure was successfully completed with the use of another contour vl stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.
Additional Manufacturer Narrative
Product analysis: a visual evaluation of the returned device found with the shaft detached at the middle section.Additionally, the bladder pigtail was observed detached.The suture string was not returned for analysis.Based on the product analysis, a visual inspection of the device into the pouch to ensure that all finished device meet specification.Therefore, the failure found (stent detached) is an issue that could have been generated by the user due the interaction with the sutrure string.Therefore the most probable root cause for this event is adverse event related to procedure since it is the most likely that the adverse event occurred during the unpacking and the device had no influence on event.A review of the device history record (dhr) was performed; no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a contour vl stent was sed during a stone removal and insertion of jj stent procedure, performed on (b)(6) 2019.According to the complainant, during unpacking, it was noticed that the stent was broken into two along shaft.The procedure was successfully completed with the use of another contour vl stent.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.

• Brand Name: CONTOUR VL
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8732378
• Report Number: 3005099803-2019-03234
• Device Sequence Number: 2572382
• Product Code: FAD
• UDI-Device Identifier: 08714729068020
• UDI-Public: 08714729068020
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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,Followup
• Report Date (Section B): 08/08/2019

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: 04/25/2021
• Device Model Number: M0061801570
• Device Catalogue Number: 180-157
• Device Lot Number: 0022043521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 08/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR