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

Model Number M0068507000

Device Problem Deformation Due to Compressive Stress (2889)

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

Event Type  malfunction  

Manufacturer Narrative

A visual examination of the returned solyx sis system revealed that the clear tube of the delivery device was deformed causing it to not deploy properly.No damage was noted to the mesh assembly.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 a solyx sis system was used on an unknown procedure on an unknown date.According to the complainant, during the procedure, the device did not deploy the sling properly.All other information is unknown.Should additional relevant details become available; a supplemental report will be submitted.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the clear tube is deformed.

• 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: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5118364
• MDR Text Key: 27298244
• Report Number: 3005099803-2015-02791
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Report Date: 09/09/2015

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: Health Professional
• Device Expiration Date: 09/30/2017
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: ML00002633
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2014
• 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