MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH SOLYX SIS SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA

Model Number M0068507000

Device Problem Bent (1059)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/27/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon 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 a solyx sis system was used during sling procedure on (b)(6) 2016.According to the complainant, during the procedure, the tip of the device became bent.The procedure was completed with another solyx sis system.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.

Manufacturer Narrative

A visual examination of the returned solyx sis system revealed that the barbed delivery device tip is bent and the knob/tube assembly is pushed forward onto the bent tip and cannot be retracted.Analysis revealed that the mesh is stretched on one side.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 during sling procedure on (b)(6) 2016.According to the complainant, during the procedure, the tip of the device became bent.The procedure was completed with another solyx sis system.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: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): 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: 6053253
• MDR Text Key: 58250299
• Report Number: 3005099803-2016-03107
• 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,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/27/2016

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 Expiration Date: 08/01/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0019539656
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/27/2016
• Initial Date FDA Received: 10/25/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2016
• 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
• Patient Age: 43 YR