MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP. CONTOUR VL SOFT PERCUFLEX MATERIAL VARIABLE LENGTH URETERAL STENT; STENT, URETERAL

Model Number M0061801550

Device Problem Stretched (1601)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/05/2018

Event Type  malfunction  

Event Description

Boston scientific, contour vl, soft percuflex material, variable length ureteral stent, 4.8 f x 22-30 cm, stent pusher arrived in the package stretched in the middle to the point where the device was unable to be utilized.

• Brand Name: CONTOUR VL SOFT PERCUFLEX MATERIAL VARIABLE LENGTH URETERAL STENT
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP. ; marlborough MA 01752
• MDR Report Key: 7957382
• MDR Text Key: 123542110
• Report Number: MW5080498
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/03/2021
• Device Model Number: M0061801550
• Device Catalogue Number: M0061801550
• Device Lot Number: 22202734
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR