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 Consequences Or Impact To Patient (2199)

Event Date 04/06/2016

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).Visual and functional analysis of the returned solyx sis system revealed that the clear tube on the delivery device is slightly buckled, most likely caused during use.Visual analysis of the solyx sis system revealed that one carrier was missing from the mesh assembly.The condition of the returned device confirmed the event.The event as reported was confirmed.The most probable root cause classification is operational context.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 a solyx single incision sling device was used on a procedure performed on (b)(6) 2016.According to the complainant, during the procedure and inside the patient, the sling tore off from the carrier.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 stable.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.This event has been deemed a reportable event based on the investigation result: the clear tube on the delivery device is slightly buckled.

• 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 Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5669240
• MDR Text Key: 45571607
• Report Number: 3005099803-2016-01342
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2016

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: Health Professional
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/25/2016
• Initial Date FDA Received: 05/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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