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 Known Impact Or Consequence To Patient (2692)

Event Date 02/08/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates cannot be determined, however, it was reported that the device was not used past expiry date.(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 pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician put too much pressure while deploying the dart through the patient¿s right side causing the dart to detach from the suture.The dart was found on the table.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 good.

Manufacturer Narrative

A visual examination of the returned uphold¿ lite with capio slim revealed that the suture on the blue with white stripe dilator was broken.The capio slim suture capturing device was not returned.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.

Event Description

It was reported to boston scientific corporation that an uphold¿ lite with capio slim was used during a pelvic floor repair procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the physician put too much pressure while deploying the dart through the patient¿s right side causing the dart to detach from the suture.The dart was found on the table.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 good.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7303066
• MDR Text Key: 101469575
• Report Number: 3005099803-2018-00512
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2020
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 21496403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2018
• Initial Date FDA Received: 02/28/2018
• Supplement Dates Manufacturer Received: 04/06/2018
• Supplement Dates FDA Received: 04/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2017
• 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