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

Model Number M0068318170

Device Problems Detachment Of Device Component (1104); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 pelvic floor repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached from the device and fell on the floor.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The condition of the returned device confirmed the event.Visual analysis revealed that the carrier was broken off and the broken section of the capio carrier was not returned.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.The investigation concluded that the most probable cause for the issue 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.An investigation was opened to address the failure of "carrier broken." per investigation, "it was determined that material brittleness is the root cause to 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." the implementation phase states that heat treatment was selected and implemented and results show that the investigation was effective.The heat treatment correction was implemented in capio pfr kits, that include capio slim suture capturing devices manufactured from lot # 22582322 onward.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a pelvic floor repair procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the capio carrier detached from the device and fell on the floor.The procedure was completed with this device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 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: 7177191
• MDR Text Key: 96823920
• Report Number: 3005099803-2017-03986
• 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,Followup
• Report Date: 02/26/2019

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: 08/31/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000041744
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/13/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/26/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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