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

Model Number M0068507000

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a solyx sis system was implanted into the patient during a procedure performed on (b)(6) 2021.During the procedure, the mesh carrier was released unintendedly from the device.The surgeon wanted to try again and do the left side of the patient; however, the physician reportedly pulled directly the mesh out by hand and the mesh got deformed and could no longer be flatted against the urethra.The procedure was completed with another solyx sis system device.There were no patient complications reported as a result of this event.

Manufacturer Narrative

(b)(4).Implanting surgeon: (b)(6).The complaint device is not expected to be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.

• Brand Name: SOLYX SIS SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, FEMA
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 12881283
• MDR Text Key: 281325802
• Report Number: 3005099803-2021-06023
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/29/2021

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: 12/17/2023
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0026534592
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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 Sex: Female