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 Consequences Or Impact To Patient (2199)

Event Date 04/08/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the device was deployed on the patient's left side and then pulled out, it was found that the suture broke.Reportedly, the dart did not detach inside the patient.Furthermore, the suture was pulled back and tensioned along the capio handle during deployment.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.

Manufacturer Narrative

Device code of 2907 captures the reportable event of dart detachment.Manufacturing site: although the most recent manufacturing site for uphold lite is boston scientific in spencer in, the reported lot involved in this complaint was manufactured by: freudenberg medical 2301 centennial boulevard, jefferson in, 47130 usa.Both the capio slim suture capturing device and uphold mesh assembly were returned.A visual assessment of the mesh assembly was performed and it revealed that the suture was broken in the area where the suture interacts with the carrier, and the dart was missing from the blue dilator.The suture frayed near where the dart was removed.Analysis of the returned capio slim device revealed that there was residue on the carrier arm.The carrier arm retracted when the plunger was pulled back.Furthermore, the dart was loaded into the delivery device and the carrier arm extended into the cage and retracted with no problem.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 is 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.An investigation was opened to address the failure of the dart detachment/suture broken issue.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6), 2019.According to the complainant, during the procedure, after the device was deployed on the patient's left side and then pulled out, it was found that the suture broke.Reportedly, the dart did not detach inside the patient.Furthermore, the suture was pulled back and tensioned along the capio handle during deployment.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.

• 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
• MDR Report Key: 8567735
• MDR Text Key: 143680623
• Report Number: 3005099803-2019-02222
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 06/03/2019

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: 04/04/2020
• 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: 04/25/2019
• Initial Date Manufacturer Received: 04/09/2019
• Initial Date FDA Received: 05/01/2019
• Supplement Dates Manufacturer Received: 05/08/2019
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 43