MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC

Model Number M0068507000

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/13/2014

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a solyx single incision sling was implanted on a patient on (b)(6) 2014.According to the complainant, during the procedure, the plastic bullet was distorted so it did not deploy.The issue occurred on the first side.There were not unusualities in the patient' anatomy encountered.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.The patient's condition was reported to be stable.

Manufacturer Narrative

The product was not returned; therefore a physical evaluation of the device could not be performed.A search of the complaint database revealed that no similar complaints exist for the specified lot.The device history record review found the device met all manufacturing specifications.The determination of a root cause could not be completed without analysis of the device involved; therefore the most probable root cause of the event is undeterminable.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): MEDVENTURE TECHNOLOGY CORPORATION; 2301 centennial boulevard; jeffersonville IN 47130
• Manufacturer Contact: ingrid matte ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 3608655
• MDR Text Key: 4173758
• Report Number: 3005099803-2014-00516
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00001621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/30/2013
• 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