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

Model Number M0068505110

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/12/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).An examination of the returned device found that in the middle of the mesh, the mesh was stretched and torn/split down the middle.Its corresponding leader loop was not cut, indicating that the mesh tore away from the leader loop.No damage was noted to the delivery device.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.It is likely that operational factors, such as user handling/technique, device tensioning/adjustment, and patient anatomy, contributed to the reported complaint.It is likely that excessive force was also encountered.Therefore, the most probable cause for this complaint is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.

Event Description

Note: this manufacturer report pertains to the second of two devices used during the procedure.It was reported to boston scientific corporation that two obtryx ii system - halo devices were used during an insertion of sub-urethral sling procedure performed on (b)(6) 2018.According to the complainant, during the procedure, for the first device, the mesh snapped from arms during pulling of the sleeves.A second device was opened and the same issue occurred.The procedure was completed with an advantage fit system.There were no patient complications reported as a result of this event.This event has been deemed reportable based on the investigation results: the mesh was stretched and torn/split down the middle.

• Brand Name: OBTRYX II SYSTEM - HALO
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• 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: 8256847
• MDR Text Key: 133353816
• Report Number: 3005099803-2018-62613
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729837565
• UDI-Public: 08714729837565
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 73207
• Device Lot Number: 0000041219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/16/2016
• 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