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

Model Number M0068507000

Device Problems Bent (1059); Break (1069); Positioning Failure (1158)

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

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

The exact age of the patient is unknown, however, it was reported the patient was over 18 years.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 a vaginal sling placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the shaft tip bent at 90 degree angle.The physician tried to straighten the shaft tip but it would not release the mesh carrier.The mesh tore and detached from the muscle.As the sling was tried to remove from the device, the shaft tip broke off outside the patient.The procedure was completed with another 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.

Manufacturer Narrative

A visual examination of the returned solyx sis system revealed that the both ends of the mesh were stretched.One carrier was detached and was not returned.Analysis also reveled that the shaft tip on the delivery device was broken and was not returned.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 a vaginal sling placement procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the shaft tip bent at 90 degree angle.The physician tried to straighten the shaft tip but it would not release the mesh carrier.The mesh tore and detached from the muscle.As the sling was tried to remove from the device, the shaft tip broke off outside the patient.The procedure was completed with another 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: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 6586818
• MDR Text Key: 75817076
• Report Number: 3005099803-2017-01470
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: (01)08714729774044(17)20190614(10)19369863
• 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: 05/03/2017

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: 06/14/2019
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 19369863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/03/2017
• Initial Date FDA Received: 05/23/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2016
• 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