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

Model Number M0068318170

Device Problems Break (1069); Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/13/2018

Event Type  malfunction  

Manufacturer Narrative

Problem code captures the reportable event of dart detachment.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 that an uphold (tm) lite w/ capio slim was used during a pelvic floor prolapse repair on (b)(6) 2018.According to the complainant, during procedure, after performing one suture, the capio slim didn't work properly.It was reported that the "groove" (cage) on the top of the capio slim was almost loose.It resulted the to dart detachment.The procedure was completed with another uphold lite w/ capio slim.There were no serious injury and no adverse patient effects that resulted from the procedure.The patient's condition after the procedure was reported to be stable.

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 that an uphold (tm) lite w/capio slim was used during a pelvic floor prolapse repair on (b)(6) 2018.According to the complainant, during procedure, after performing one suture, the capio slim didn't work properly.It was reported that the "groove" (cage) on the top of the capio slim was almost loose.It resulted the to dart detachment.The procedure was completed with another uphold lite w/capio slim.There were no serious injury and no adverse patient effects that resulted from the procedure.The patient's condition after the procedure was reported to be stable.Additional information received on october 16, 2018.The dart detached after performing one side of the patient.It was deployed two times before it detached on the patient's right side.The capio suture was reportedly not tensioned.It was also reported that the dart did not detach inside the patient.

• 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: 7945571
• MDR Text Key: 123043799
• Report Number: 3005099803-2018-60744
• 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: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2019
• Device Model Number: M0068318170
• Device Catalogue Number: 72441
• Device Lot Number: 0000042876
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR