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); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/05/2018

Event Type  Injury  

Manufacturer Narrative

(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.No damage was noted to the capio slim suture capturing device.Regarding the mesh assembly, no damage was noted to the mesh material itself.The leader loops were intact.On the blue/white dilator, the suture was broken in the area where the dart interacts with the carrier.The detached portion of suture containing the dart was returned.On the blue dilator, no damage was noted; the dart and suture were intact.The complaint investigation 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.The 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.The investigation is in the implementation phase and no further escalation is required.

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) 2018.According to the complainant, during the procedure, the device did not penetrate the tissue on the patient's left side.The procedure was completed with another uphold lite with capio slim device.There is no known impact or consequence to the patient.The patient's condition at the conclusion of the procedure was reported to be stable.This event has been deemed reportable based on the investigation results: the suture broke and the detached portion of the suture containing the dart was returned.

• 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: 8293961
• MDR Text Key: 134634497
• Report Number: 3005099803-2019-00423
• 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: 01/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2019
• Is this an Adverse Event Report?: Yes
• 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: 0000061420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/18/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Weight: 59