MAUDE Adverse Event Report: BOSTON SCIENTIFIC ADVANTAGE FIT SYSTEM; TRANSVAGINAL MID-URETERAL SLING

Model Number M0068502110

Device Problems Difficult to Insert (1316); Material Puncture/Hole (1504)

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

Event Date 02/16/2018

Event Type  malfunction  

Event Description

Boston scientific, advantage fit system, transvaginal mid-urethral sling, trocar punctured through blue sheath of implant.Unable for implant to be inserted.

• Brand Name: ADVANTAGE FIT SYSTEM
• Type of Device: TRANSVAGINAL MID-URETERAL SLING
• Manufacturer (Section D): BOSTON SCIENTIFIC; marlborough MA 01752
• MDR Report Key: 7285634
• MDR Text Key: 100694774
• Report Number: MW5075379
• Device Sequence Number: 1
• Product Code: PAI
• 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: 02/16/2018

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: 09/26/2020
• Device Model Number: M0068502110
• Device Catalogue Number: M0068502110
• Device Lot Number: 21182807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• 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: 52 YR