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

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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, the dart detached from the suture and was found inside the capio device.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 sacrospinous ligament fixation procedure on (b)(6) 2018.According to the complainant, the dart detached from the suture and was found inside the capio device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

A visual examination of the returned uphold lite revealed that the suture on the blue with white stripe dilator is broken.The dart was returned with a small amount of suture attached to it.Visual analysis revealed no damage to the capio slim suture capturing device.Functional analysis revealed that the device functions as intended.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.However, the investigation concluded that the most probable cause for this event is manufacturing process design because the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation concluded that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in suture severing.The issue is under investigation and a correction has not yet been implemented.

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, the dart detached from the suture and was found inside the capio device.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

The assigned complaint investigation conclusion code for this event is supplier manufacturing process design because the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.

• 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: 7384196
• MDR Text Key: 103920898
• Report Number: 3005099803-2018-00855
• 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,Followup
• Report Date: 03/09/2018

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: 01/10/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 21598241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2018
• Initial Date Manufacturer Received: 03/09/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 05/04/2018; 07/17/2018
• Supplement Dates FDA Received: 05/16/2018; 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1