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

Model Number M0068318170

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/02/2018

Event Type  malfunction  

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 corporation that an uphold¿ lite with capio slim was used during a vaginal vault prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on the first throw of the first leg of the mesh into the right sacrospinous ligament of the patient, the suture broke and was removed from the patient.Reportedly, before the suture broke, the physician applied counter tension when the suture was pulled back.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 fine.

Manufacturer Narrative

The investigation concluded that the most probable cause for this event is supplier manufacturing process design, and not manufacturing process design as previously reported, because the design or validation of a suppliers manufacturing process was not sufficient to ensure the finished device met the intent of the design.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim was used during a vaginal vault prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on the first throw of the first leg of the mesh into the right sacrospinous ligament of the patient, the suture broke and was removed from the patient.Reportedly, before the suture broke, the physician applied counter tension when the suture was pulled back.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 fine.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a vaginal vault prolapse procedure performed on (b)(6) 2018.According to the complainant, during the procedure, on the first throw of the first leg of the mesh into the right sacrospinous ligament of the patient, the suture broke and was removed from the patient.Reportedly, before the suture broke, the physician applied counter tension when the suture was pulled back.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 fine.

Manufacturer Narrative

A visual examination of the returned uphold¿ lite with capio slim revealed that the suture on the blue dilator was broken.The dart was located behind the catch of the capio slim cage.There was a small amount of suture attached to it.Analysis revealed no damage to the capio slim suture capturing device.Functional analysis revealed that the device functioned as intended.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.However, the investigation concluded that the most probable cause for this event is manufacturing process design as the design or validation of the manufacturing process was not sufficient to ensure the finished device met the intent of the design.The 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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: UPHOLD¿ LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7541955
• MDR Text Key: 109184956
• Report Number: 3005099803-2018-01662
• 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,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/06/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0021712236
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Initial Date Manufacturer Received: 05/02/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 06/13/2018; 06/26/2018
• Supplement Dates FDA Received: 06/21/2018; 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention