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

Lot Number ML00003298

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/29/2015

Event Type  malfunction  

Event Description

Pt undergoing a vaginal suspension and paravaginal repair with mesh placement.Surgeon using the uphold lite with capio slim to attach mesh grafts to ligaments.In the process of placing the capio arm on the pt's left side, the small bullet/ball on the end of the suture broke off.It was not attached to the capio arm.Exploration could not find bullet/ball.X-ray did not reveal bullet/ball.

• Brand Name: UPHOLD LITE WITH CAPIO UPHOLD
• Type of Device: VAGINAL SUPPORT SYSTEM
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5344472
• MDR Text Key: 35109568
• Report Number: MW5058885
• Device Sequence Number: 1
• Product Code: OTP
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: ML00003298
• Other Device ID Number: GTIN 08714729838200
• Was Device Available for Evaluation?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR