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

Model Number M0068318170

Device Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/20/2019

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).An examination of the returned capio slim suture capturing device and mesh assembly was performed.On the mesh assembly, the suture on the blue dilator was broken in the area where the dart interacts with the carrier.The cage of the capio suture device was removed and the dart was found inside.The leader loops, protective sleeves, and dilators were intact.No damage was noted to the suture and dart on the blue/white dilator, and to the mesh material itself.On the capio slim suture capturing device, no damage was noted.The intact dart was loaded into the delivery device and the carrier was extended into the cage and retracted without issues.Although the lot number of the device was not reported, a customer shipment history search was performed to identify the most probable lot associated with the complaint.This search revealed that the most probable lot numbers are 21712236, 21781540, and 21724597.A device history record (dhr) review performed on the identified lots confirms that the device was manufactured in accordance with the device master record and met manufacturing specifications at the time of release to distribution.An investigation determined that the design of the carrier allows the fiber portion of the suture to interact with the sharp edge of the carrier, resulting in the suture severing.Therefore, the investigation concluded that the most probable cause for the dart detachment/suture broken issue is design inadequate for purpose, which indicates that problems were traced to design/design features of the device that do not support or do interfere with the intended purpose of the device.There is an investigation in place to address this issue.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with uphold procedure performed on (b)(6) 2019.According to the complainant, during the procedure, capio cage was not catching the dart.The procedure was completed with another uphold lite with capio slim device.There were no consequences or impact to the patient asa result of the event.The patient's condition at the conclusion of the procedure was reported to be great.This event has been deemed reportable based on the investigation results: the suture on the blue dilator was broken in the aea where the dart interacts with the carrier.The cage of the capio suture device was removed and the dart was found inside.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an anterior repair with uphold procedure performed on (b)(6), 2019.According to the complainant, during the procedure, capio cage was not catching the dart.The procedure was completed with another uphold lite with capio slim device.There were no consequences or impact to the patient as a result of the event.The patient's condition at the conclusion of the procedure was reported to be great.This event has been deemed reportable based on the investigation results: the suture on the blue dilator was broken in the area where the dart interacts with the carrier.The cage of the capio suture device was removed and the dart was found inside.Clarification received on april 9, 2019.The device for the event described above was discarded and was not returned to bsc.Therefore, the investigation results do not apply to this complaint, and this complaint has been deemed non-reportable.

Manufacturer Narrative

Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h10: the complaint device is not expected to be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.Block h11: although a device was returned under this complaint, a clarification was later received stating that device for the reported complaint was not returned.Based on this information, blocks b5, d10, f10, h3, and h6 have been updated.The analysis on the returned device will be sent under mfr report# 3005099803-2019-02467.

• Brand Name: UPHOLD LITE
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR PELVIC ORGAN PROLAPSE, TRANSVAGIN
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8512552
• MDR Text Key: 141924715
• Report Number: 3005099803-2019-01838
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 02/26/2019
• Date Manufacturer Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1