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

Model Number M0068507010

Device Problem Difficult to Advance (2920)

Patient Problem Internal Organ Perforation (1987)

Event Date 12/01/2021

Event Type  Injury  

Manufacturer Narrative

The exact age of the patient is unknown.However, it was reported the patient was over 18 years.(b)(4).The complainant indicated that the device was disposed and 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.

Event Description

Note: this manufacturer report pertains to the first of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx blue sis system devices were used during a mid urethral sling + total hysterectomy + suspension + anterior and posterior repair procedure performed on (b)(6) 2021.During the procedure, the physician experienced difficulty advancing the device and the mesh could not be placed due to an unusual anatomy, very large pubic bone and very distended bladder.Reportedly, the mesh could not be successfully implanted without hitting the bladder so the mesh was removed.A second solyx device was then opened and the physician again experienced difficulty advancing the device.The second mesh was then completely removed from the patient; however, the event caused the shaft tip to bend and the bladder was perforated.Reportedly, there was no intervention done to treat bladder perforation as it will heal on its own.The sling placement procedure was cancelled and rescheduled in three months' time; however, the rest of the procedure was completed.

• 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: 13044542
• MDR Text Key: 284475197
• Report Number: 3005099803-2021-07856
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: M0068507010
• Device Lot Number: 0028178451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2021
• 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 Outcome(s): Other
• Patient Sex: Female
• Patient Race: White