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

Model Number M0068318170

Device Problem Material Separation (1562)

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

Event Date 05/30/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 was used during a pelvic organ prolapse anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the surgeon had placed both arms into the sacrospinous ligament and as pulling the arms to tack down the uphold lite at the cuff, the mesh on the patient's right side disengaged from the plastic sleeve and came out of the sacrospinous ligament.The surgeon removed the uphold lite and the procedure was completed with another uphold¿ lite with capio slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a pelvic organ prolapse anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the surgeon had placed both arms into the sacrospinous ligament and as pulling the arms to tack down the uphold lite at the cuff, the mesh on the patient's right side disengaged from the plastic sleeve and came out of the sacrospinous ligament.The surgeon removed the uphold lite and the procedure was completed with another uphold lite with capio slim.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.

Manufacturer Narrative

A visual examination of the returned uphold lite with capio slim could not confirm the event as the leader loops were cut and the mesh was not torn.The mesh was returned separated from the sleeve/dilator assembly.The mesh was stretched, but was not torn.The long leader loops were attached to each mesh leg as intended and were cut.The short leader loops were not attached to the mesh.However, both the long and short leader loops were attached to each sleeve/dilator assembly and were cut.The sleeves on the sleeve/dilator assemblies were cut.Darts were attached to each suture.The capio slim suture capturing device was not returned.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.The review and analysis of all available information fails to indicate a root cause or probable root cause.It is not possible to determine if there was an issue with the leader loops because the customer cut them.Therefore, the root cause of this complaint is undeterminable.

• 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: 7643791
• MDR Text Key: 112557144
• Report Number: 3005099803-2018-02005
• 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,health
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 03/12/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000058944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Date Manufacturer Received: 08/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 77 YR