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 Tissue Damage (2104)

Event Date 03/29/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).An examination of the returned capio slim suture capturing device and uphold mesh assembly revealed that on the blue dilator, the dart detached from the suture near to where the suture interacts with the carrier.The dart was returned inside of the capio cage.The protective sleeves, leader loops and mesh appeared intact.There was no damage noted to the capio slim suture capturing device.The dart of the blue/white dilator was loaded into the capio slim device.The carrier and dart were extended into the cage and retracted.No problems were found.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.An investigation determined that the root cause is inadequate design/design controls: 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.An investigation is in place to address the failure of dart detachment.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a repair anterior, cystourethroscopy, insertion of mesh for pelvic floor defect procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the suture broke during deployment of the capio device inside the patient.Reportedly, the dart could not be retrieved and was left inside the patient.At the six-week post-operative check-up, mild atrophy was reported, but the patient's condition was noted to be otherwise within normal limits.

Manufacturer Narrative

Problem code 2907 captures the reportable event of dart detachment.An examination of the returned capio slim suture capturing device and uphold mesh assembly revealed that on the blue dilator, the dart detached from the suture near to where the suture interacts with the carrier.The dart was returned inside of the capio cage.The protective sleeves, leader loops and mesh appeared intact.There was no damage noted to the capio slim suture capturing device.The dart of the blue/white dilator was loaded into the capio slim device.The carrier and dart were extended into the cage and retracted.No problems were found.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.An investigation determined that the the root cause is inadequate design/design controls: 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.An investigation is in place to address the failure of dart detachment.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a repair anterior, cystourethroscopy, insertion of mesh for pelvic floor defect procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the suture broke during the first deployment of the capio device through the patient's right sacrospinous ligament.Reportedly, the dart was lost in the belly of the coccygeus muscle and could not be retrieved and was left inside the patient.The procedure was completed by opening a new mesh and a capio device, and the mesh arms were placed in the bilateral sacrospinous ligament.At the six-week post-operative check-up, mild atrophy was reported, but the patient's condition was noted to be otherwise within normal limits.

• 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: 8497730
• MDR Text Key: 141429857
• Report Number: 3005099803-2019-01642
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0021377535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2019
• Initial Date Manufacturer Received: 03/11/2019
• Initial Date FDA Received: 04/09/2019
• Supplement Dates Manufacturer Received: 04/17/2019
• Supplement Dates FDA Received: 05/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 86