MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH OBTRYX II SYSTEM; MESH, SURGICAL, SYNTHETIC

Model Number M0068505110

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Visual analysis of the returned device showed that the mesh was stretched.The dilators, sleeves, centering tab and delivery device were not returned.The most probable root cause classification is operational context.A review of the dhr review confirmed that all acceptance records demonstrated that the device was manufactured in accordance with device master record.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.

Event Description

It was reported to boston scientific corporation that an obtryx ii system was used during a mid-urethral sling placement procedure on (b)(6) 2016.According to the complainant, during procedure closure, the sling was noticed to have loosened up inside the patient.The procedure was finished using another obtryx 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 fine.

• Brand Name: OBTRYX II SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC
• 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: 5621478
• MDR Text Key: 44124633
• Report Number: 3005099803-2016-01108
• 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
• Report Date: 04/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 02/01/2019
• Device Model Number: M0068505110
• Device Catalogue Number: 850-511
• Device Lot Number: ML00003453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2016
• 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