MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE WITH CAPIO SLIM; VAGINAL SUPPORT SYSTEM

Model Number M0068318170

Device Problems Break (1069); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 08/28/2018

Event Type  Injury  

Event Description

The suture used / included with the device would not pull through the outer sheath and eventually broke while implementation was occurring causing the mesh to not be sutured properly.

• Brand Name: UPHOLD LITE WITH CAPIO SLIM
• Type of Device: VAGINAL SUPPORT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA
• MDR Report Key: 7885205
• MDR Text Key: 120768387
• Report Number: MW5079857
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2020
• Device Model Number: M0068318170
• Device Catalogue Number: M0068318170
• Device Lot Number: 0000052594
• Was Device Available for Evaluation?: No
• 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 Outcome(s): Required Intervention
• Patient Age: 31 YR