MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION UPHOLD LITE; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN

Catalog Number 72441

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 12/19/2018

Event Type  Injury  

Manufacturer Narrative

No information regarding the event date.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.An examination of the returned uphold lite with capio slim found that the suture was broken on the mesh assembly's blue/white dilator.The portion of the broken suture that included the dart appeared detached, and was not returned.No damage was noted to the capio slim suture capturing device.The investigation concluded that the most probable cause of dart detachment/suture broken issue is manufacturing deficiency, which indicates that problems were traced to the manufacturing process.An investigation was opened to address the failure of the dart detachment/suture broken issue.The investigation determined that the fiber portion of the suture interacts with the sharp edge of the carrier, resulting in the suture severing.Modifications to the manufacturing process, including the order of the process steps, harperization time, and the sizing of the pins were studied to determine their effect of the suture cutting rate.The investigation is in the implementation phase.No further escalation is required.

Event Description

An opened uphold lite with capio slim device was returned to boston scientific corporation.The returned device had the suture broken on the mesh assembly's blue/white dilator.The portion of the broken suture that includes the dart appeared detached, and was not returned.There was no damage noted to the capio slim suture capturing device.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date. should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8252629
• MDR Text Key: 133211927
• Report Number: 3005099803-2018-62561
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 01/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 72441
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Date Manufacturer Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other