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

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

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

Event Date 05/30/2018

Event Type  Injury  

Manufacturer Narrative

Device component code is related to device problem code for the problem of needle 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 corporation that an uphold¿ lite with capio slim was used during an anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, during deployment of the suture into the sacrospinous ligament, the black head of the capio slim device split apart at the top end and it cut the dart off the suture.The procedure was completed with another uphold lite mesh and a 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 fine.

Manufacturer Narrative

The condition of the returned device revealed that the dart detached.Capio slim components separated/tore apart could not be confirmed because the user pried the two halves of the capio slim head apart.Analysis revealed that the suture on the blue with white stripe dilator was broken and the remainder of the suture including the dart was not returned.The capio slim head was returned detached from the rest of the device.The rest of the device was not returned.There were tool marks on the side of the capio slim head halves indicating that the user pried the two halves apart.All rivets were attached.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu)/product label.However, the investigation concluded that the most probable cause for this event is supplier manufacturing process design because the design or validation of the supplier¿s manufacturing process was not sufficient to ensure the finished device met the intent of the design.An investigation concluded that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in suture severing.The issue is under investigation and a correction has not yet been implemented.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during an anterior repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, during deployment of the suture into the sacrospinous ligament, the black head of the capio slim device split apart at the top end and it cut the dart off the suture.The procedure was completed with another uphold lite mesh and a 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 fine.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7624566
• MDR Text Key: 111843384
• Report Number: 3005099803-2018-01957
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/19/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0000053680
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2017
• 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): Other