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

Model Number M0068318170

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

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

Event Date 02/28/2019

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).An examination of the returned mesh assembly and capio slim was performed.There were no visual issues noted on the mesh assembly and on the outside of the capio slim device.During the functional test, the plunger could be depressed but there was no shaft movement.A small metal piece protruded from the head when the plunger was actuated.The capio head was then opened and there was only a small piece of the carrier identified inside the device.It was then determined that the carrier had broken.An investigation was opened to address the failure of carrier detachment.It was determined that material brittleness is the root cause of the carrier breaking as evidenced by the brittle cracks in the material detected in the complaint units.The material brittleness is an inherent property determined by the heat treatment used for the parts.An update to the heat treatment was implemented in (b)(6) 2018; however, the complaint device was manufactured prior to implementation of these changes.Based on all gathered information, that investigation concluded that the most probable cause for the failure of carrier detachment is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a prolapse correction procedure performed on (b)(6) 2019.According to the complainant, the device was defective.The procedure was completed with another uphold lite with capio slim.This event has been deemed reportable based on the investigation results: the carrier had broken.

• 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 MIS INC; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 9110090
• MDR Text Key: 159963475
• Report Number: 3005099803-2019-04558
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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: 09/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000058081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/06/2017
• 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