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

Model Number M0068318170

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/07/2019

Event Type  Injury  

Manufacturer Narrative

(b)(6).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 uphold mesh revealed that on the blue/white dilator, the dart was missing from the suture near to where the suture interacts with the carrier.The dart was not returned.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 dilator was loaded into the capio slim device.The carrier and dart were extended and retracted into the cage with no issue.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 device was used during an anterior prolapse repair with uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, upon first deployment of the device, the dart was unable to penetrate the tissue.It was then noticed that the dart detached from the suture.Reportedly, the dart did not detach inside the patient.The procedure was completed with another uphold lite with capio slim.There was no serious injury reported as a result of the 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
• 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: 8485673
• MDR Text Key: 141008385
• Report Number: 3005099803-2019-01640
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• 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: 03/26/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/05/2017
• 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
• Patient Age: 64 YR
• Patient Weight: 64