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

Model Number M0068318170

Device Problems Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/15/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An examination of the returned delivery device and mesh assembly was performed.No damage was noted to the capio slim suture capturing device.The dart of the blue dilator was loaded into the capio slim device.The carrier and dart were extended and retracted into the cage with no issue.On the mesh assembly, no damage was noted to the mesh material itself.The leader loops were intact.The dilator and suture were detached near the distal end of the blue/white dilator.The detached section of the suture was returned.No other damage was noted to the detached section.On the blue dilator, no damage was noted; the dart and suture were intact.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.It was reported by the customer that the event happened "inside the patient".Based on this information, it is probable that operational factors, such as the user handling/technique and patient anatomy, contributed to the reported complaint of dilator torn.Therefore, the investigation concluded that the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that an uphold lite with capio slim device was used during an uphold lite procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the mesh arm was torn inside the patient.The procedure was completed with another uphold lite with capio slim device.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 stable and good.This event has been deemed reportable based on the investigation results: the dilator and suture were broken/detached near the distal end of the blue/white dilator.The detached section of the suture was returned.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 8553451
• MDR Text Key: 143247875
• Report Number: 3005099803-2019-02100
• Device Sequence Number: 1
• Product Code: OTP
• UDI-Device Identifier: 08714729839200
• UDI-Public: 08714729839200
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K122459
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2019

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: 09/30/2021
• Device Model Number: M0068318170
• Device Catalogue Number: 831-817
• Device Lot Number: 0022726827
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2019
• Initial Date FDA Received: 04/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/09/2018
• 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