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 03/05/2019

Event Type  Injury  

Manufacturer Narrative

The event date was approximated to (b)(6) 2019, the date the complaint was reported, as there was no event date reported.(b)(4).Manufacturing site: although the current manufacturing site for uphold lite is boston scientific in (b)(4) the reported lot involved in this complaint was manufactured by: freudenberg medical (b)(4).An examination of the returned capio slim suture capturing device and mesh assembly was performed.There was no damage noted to the capio slim suture capturing device.The dart on the blue dilator was loaded in the suturing device.The carrier and dart extended into the cage and retracted with no issue.On the mesh assembly, no damage was noted to the mesh material itself.The leader loops, and protective sleeves were intact.On the blue and white dilator, the suture was broken in the area where the dart interacts with the carrier.The portion of the detached suture containing the dart was not returned.The cage of the capio device was removed and the dart was not found inside the cage.On the blue/white dilator, no damage was noted; the dart and suture were intact.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, it was determined that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.Therefore, the investigation concluded that the most probable cause for the dart detachment/suture broken 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 "dart detachment/suture broken.".

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during a pelvic floor repair procedure performed on an unknown date.According to the complainant, during the procedure, the product was received damage and did not work properly when used.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.This event has been deemed reportable based on the investigation results: on the blue dilator, the suture was broken in the area where the dart interacts with the carrier.The portion of the detached suture containing the dart was not returned.The cage of the capio device was removed and the dart was not found inside the cage.

• 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: 8553371
• MDR Text Key: 143209346
• Report Number: 3005099803-2019-02166
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/11/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000062156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Date Manufacturer Received: 03/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other