MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number M0068505110

Device Problem Torn Material (3024)

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

Event Date 04/11/2018

Event Type  malfunction  

Manufacturer Narrative

A visual examination of the returned device revealed that the that the leader loops are not cut on either sleeve.The mesh is stretched and broken which allowed it to unravel to where the leader loop is attached to the mesh within the sleeve.As a result, the mesh detached from the sleeve and leader loop prematurely, without cutting the leader.The delivery device revealed no damage.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.The investigation concluded that this complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedural factors encountered during the procedure, performance of the device was limited.The most probable root cause classification is operational context.

Event Description

It was reported to boston scientific corporation that an obtryx ii system was used during an insertion of transobturator sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the sleeve detached from the mesh prior to cutting the suture (leader loop).The tape was then removed and the procedure was completed with another obtryx ii system.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.This event has been deemed reportable based on the investigation results: mesh torn.

• Brand Name: OBTRYX II SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 7638998
• MDR Text Key: 112377513
• Report Number: 3005099803-2018-01942
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K121754
• 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: 06/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 21093241
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2017
• 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