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

Model Number M0068318170

Device Problems Device-Device Incompatibility (2919); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Investigation of the returned uphold lite with/ capio slim revealed that there were no issues found on the capio slim device.The mesh assembly was received in three pieces, and there were signs of use.The mesh appeared to be torn on one side and the other leg was significantly curled.There was residue and debris in the mesh material.The leader loops were cut in the dilator assemblies from the mesh consistent with normal procedure.Additionally, the dart from one of the detached dilator assemblies was loaded into the delivery device and deployed with no issue.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.Based on the condition of the returned device, it is likely that operational factors lead to the user encountering difficulty during the final adjustments and mesh placement that lead to the subsequent removal of the device.Therfore, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the physician had difficulty loading the suture in the capio carrier.The procedure was completed with another uphold lite with capio slim.There was no serious injury reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.This event has been deemed reportable based on the investigation results: the mesh appeared to be torn on one side.

• 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): FREUDENBERG MEDICAL; 2301 centennial boulevard; jefferson IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8772412
• MDR Text Key: 150436661
• Report Number: 3005099803-2019-03385
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/04/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000061422
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 78 YR