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

Model Number M0068504110

Device Problem Detachment Of Device Component (1104)

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

Event Date 04/26/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and 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 implanted during a transobturator tape procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the blue dilator detached from the sleeve upon pulling out the mesh.The procedure was completed with another obtryx ii system.There were no patient complications reported as a result of this event.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 found that one sleeve is detached from its dilator.The inside of the dilator shows signs of adhesion.The delivery device was not returned.Review and analysis of all available information indicated the most probable root cause for this event was operational context as device performance was limited due to anatomical/procedural factors.A search of the complaint database revealed that no other complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.

Event Description

It was reported to boston scientific corporation that an obtryx ii system was implanted during a transobturator tape procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the blue dilator detached from the sleeve upon pulling out the mesh.The procedure was completed with another obtryx ii system.There were no patient complications reported as a result of this event.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: 6568521
• MDR Text Key: 75329720
• Report Number: 3005099803-2017-01401
• Device Sequence Number: 1
• Product Code: OTN
• 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,Followup
• Report Date: 04/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2019
• Device Model Number: M0068504110
• Device Catalogue Number: 850-411
• Device Lot Number: 0000050208
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/23/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2016
• 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