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

Model Number M0068507010

Device Problems Difficult to Advance (2920); Material Twisted/Bent (2981)

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 device has been received for analysis.Upon completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

Note: this manufacturer report pertains to the second 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.

Event Description

Note: this manufacturer report pertains to the second 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.

Manufacturer Narrative

Block a2: the exact age of the patient is unknown.However, it was reported the patient was over 18 years.Block h6: patient code e21140 captures the reportable event of bladder perforation.Device code a040609 captures the reportable event of shaft tip bent.Block h10: investigation of the returned single incision sling device revealed that the tip of the delivery device was bent, and the mesh was stretched on both sides.Small amounts of tissue were observed near the mesh carriers.The reported complaint of shaft tip confirmed.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.Based on the available information, it is likely that procedural factors, such as user handling technique during placement or advancement of the device, resulted in excessive force applied to the delivery device and mesh.Therefore, the investigation concluded that the most probable cause for this complaint is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on the event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

• 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: 13044575
• MDR Text Key: 282559526
• Report Number: 3005099803-2021-07855
• 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,Followup
• Report Date: 02/10/2022

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?: Yes
• Device Operator: Health Professional
• Device Model Number: M0068507010
• Device Lot Number: 0028178451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/20/2021
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 02/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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