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

Model Number M0068505110

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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 obtryx ii system was used during an anterior repair procedure on (b)(6) 2016.According to the complainant, during the procedure, the mesh got torn.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.

Manufacturer Narrative

Visual evaluation of the returned obtryx ii, halo, single unit revealed that a 9 cm piece of stretched mesh was returned.The remainder of the mesh and the blue centering tab was not returned.Both dilators were returned with sleeves and leader loops attached.Analysis revealed no damage to either 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.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 anterior repair procedure on (b)(6) 2016.According to the complainant, during the procedure, the mesh got torn.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.

• Brand Name: OBTRYX II SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5902740
• MDR Text Key: 52948715
• Report Number: 3005099803-2016-02491
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121754
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/01/2016

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: Physician
• Device Expiration Date: 06/29/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: 0000035632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2016
• Initial Date FDA Received: 08/24/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1