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

Model Number M0068318170

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2019

Event Type  malfunction  

Manufacturer Narrative

The patient's weight is (b)(6).(b)(4).Manufacturing site although the current manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: (b)(4).One capio slim device was received with the uphold lite mesh assembly.The mesh assembly was received in three sections.A visual assessment of the mesh assembly was performed and revealed that the mesh was damaged with a tear in the white center line.The mesh was curling and had residue which was an indicative of use.The leader loops were cut at the mesh and separated from the mesh assembly.The protective sleeves, dilators, sutures, and darts were all intact.A visual assessment of the capio device was conducted and revealed that there was a residue on the carrier arm and on the head of the device.No other issues were found.A functional examination of hte capio slim device was done by loading the dart into the device, and the carrier with the dart could be extended into the cage.The carrier arm reacted with no problems found.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 returned device, it is probable that operational factors, such as the user handling/technique and patient anatomy, resulted in the user encountering difficulty during the procedure and subsequently damaging the mesh and cutting the leader loop.Therefore, the complaint investigation conclusion code selected 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 uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the dart was unable to penetrate the tissue after several time on both patient's sides.The procedure was completed with another of the uphold lite with capio slim device.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.This event has been deemed reportable based on the investigation results: the mesh was torn near the white center line.

• 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: 8614291
• MDR Text Key: 145218404
• Report Number: 3005099803-2019-02272
• 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: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2019
• 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: 04/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2019
• 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: 60 YR