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 04/19/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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, the dart did not penetrate the tissue and subsequently, the dart detached from the suture after deployment of the capio device.However, the dart did not detach and fall into the patient.Reportedly, the suture was pulled back and tensioned along the capio handle during deployment of the device.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.

Manufacturer Narrative

Blocks f10 and h6: device code 2976 captures the reportable event of dart detachment.Block g1: 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.Block h10: a visual examination of the returned capio slim device revealed that there was significant residue on the carrier arm.The carrier arm was skewed slightly to one side when deployed, however it was still caught by the cage when fully deployed.A visual inspection of the mesh assembly was also conducted and there were no issues noted.Darts, sutures, dilators, leader loops, and mesh assembly were all intact.Furthermore, during the functional test, the dart was loaded into the capio device.The carrier arm was deployed and the dart was deployed into the cage.No issues with the device function were noted.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.It is possible that misaligned carrier is a result of torquing the device while the arm was deployed.It is possible that operational factors, such as user handling/technique and patient anatomy resulted in the user having trouble and torquing the device.Therefore, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.

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, the dart did not penetrate the tissue and subsequently, the dart detached from the suture after deployment of the capio device.However, the dart did not detach and fall into the patient.Reportedly, the suture was pulled back and tensioned along the capio handle during deployment of the device.The procedure was completed with another uphold lite with capio slim.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable and fine.

• 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: 8625698
• MDR Text Key: 145614686
• Report Number: 3005099803-2019-02511
• 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: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2019
• 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: 05/13/2019
• Date Manufacturer Received: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 52