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

Model Number M0068318170

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 02/26/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2019, the date the device was received at boston scientific corporation, as no event date was reported.(b)(4).An examination of the returned capio slim suture capturing device and mesh assembly was performed.On the mesh assembly, the suture on the blue dilator was broken in the area where the dart interacts with the carrier.The cage of the capio suture device was removed and the dart was found inside.The leader loops, protective sleeves, and dilators were intact.No damage was noted to the suture and dart on the blue/white dilator, and to the mesh material itself.On the capio slim suture capturing device, no damage was noted.The intact dart was loaded into the delivery device and the carrier was extended into the cage and retracted without issues.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, an investigation 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 issue 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.There is an investigation in place to address this issue.Please note: this device was originally thought to be associated with another complaint and a report was sent based on the investigation results for that event, under mfr report # 3005099803-2019-01838.It was subsequently confirmed that this device was not associated with that reported event, and therefore it is being captured as a separate event and sent in this report (3005099803-2019-02467).

Event Description

An uphold lite with capio slim device was returned to boston scientific corporation.The returned device had the suture on the blue dilator broken in the area where the dart interacts with the carrier.The cage of the capio suture device was removed and the dart was found inside.All other information is unknown.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 8597117
• MDR Text Key: 144678040
• Report Number: 3005099803-2019-02467
• 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: 05/09/2019

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: 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: 02/26/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/09/2019
• 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