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

Model Number M0068318170

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2018

Event Type  malfunction  

Manufacturer Narrative

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 sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, during the procedure, the capio cage would not catch the dart.The device was deployed several times then the capio carrier cracked.The procedure was completed with another uphold lite with capio slim device.The patient's condition at the conclusion of the procedure was reported to be stable.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, during the procedure, the capio cage would not catch the dart.The device was deployed several times then the capio carrier cracked.The procedure was completed with another uphold lite with capio slim device.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

A visual examination of the returned uphold lite with capio slim revealed that the proximal end of the capio slim was separated, indicating that the user most likely torqued the device while in use.As a result, the head lifts off the shaft when actuated preventing the carrier from actuating.All rivets were intact.The capio slim head halves were separated during analysis.There was a heavy debris inside the head and the carrier was not broken.The uphold lite 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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7638857
• MDR Text Key: 112415086
• Report Number: 3005099803-2018-01958
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000060409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 66