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

Model Number M0068318170

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/10/2018

Event Type  malfunction  

Manufacturer Narrative

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 uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, inside the patient, the capio cage was broken and was unable to catch the dart.One end of the capio cage was detached, but it was still attached to the rest of the device at the other end.The procedure was completed with uphold¿ lite.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Analysis of the returned uphold lite with capio slim device revealed that the capio cage was damaged and unable to catch the dart, thereby confirming the reported event.Visual analysis revealed that the cage on the capio slim suture capturing device was partially detached from the capio head and was bent.Visual analysis also revealed no damage to the uphold lite mesh assembly.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.Since the capio slim showed no evidence consistent with torqueing while in use, the assigned complaint investigation conclusion code for this event is undeterminable.A complaint with a root cause classification of undeterminable indicates review and analysis of all available information fails to indicate a root cause or probable root cause.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an uphold lite procedure performed on (b)(6) 2018.According to the complainant, during the procedure, inside the patient, the capio cage was broken and was unable to catch the dart.One end of the capio cage was detached, but it was still attached to the rest of the device at the other end.The procedure was completed with uphold lite.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 - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7734863
• MDR Text Key: 115543360
• Report Number: 3005099803-2018-02377
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/26/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000060409
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2018
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 62