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

Model Number M0068318170

Device Problem Misfire (2532)

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

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a anterior repair procedure performed.According to the complainant, during the procedure, the device had a misfire.The procedure was completed with another uphold¿ lite with capio slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a anterior repair procedure performed.According to the complainant, during the procedure, the device had a misfire.The procedure was completed with another uphold¿ lite with capio slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

An examination of the returned device revealed that there was no damage to the capio slim suture capturing device and it functioned as intended.The mesh assembly was not returned for analysis.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.

• Brand Name: UPHOLD¿ LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7445742
• MDR Text Key: 106029212
• Report Number: 3005099803-2018-01152
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• 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,health
• Type of Report: Initial,Followup
• Report Date: 03/30/2018

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: 02/06/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 21712236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Initial Date Manufacturer Received: 03/30/2018
• Initial Date FDA Received: 04/19/2018
• Supplement Dates Manufacturer Received: 04/24/2018
• Supplement Dates FDA Received: 05/22/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1