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

Model Number M0068507000

Device Problem Positioning Failure (1158)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2020, the date bsc was first made aware of the event, as no event date was reported.(b)(4).One solyx mesh assembly and one solyx delivery device were received.Visual examination found that the device had signs of use.There was residue/debris on the mesh assembly.One end of the mesh material appeared to have been stretched.There was a damage to the deployment mechanism on the delivery device.It was slightly accordioned, as though it had been compressed.A functional test was performed.Each carrier was loaded onto and deployed from the returned delivery device.Both carriers were released from the device with no issue.A device history record review was performed and found that there were no deviations during the manufacturing of the device lot that would have contributed to the reported event.Based on the damaged to the returned device, it is likely that procedural factors, including procedural debris in the dissection pathway during advancement, could have interfered with the device advancement and deployment and contributed to user having difficulty during deployment and subsequently damaging the delivery device and mesh material; confirming the reported complaint.Therefore, the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on event.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a sling for incontinence procedure for treatment of stress urinary incontinence.According to the complainant, during the procedure, the device would not deploy inside the patient.The procedure was completed with another solyx sis system device.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.

Event Description

It was reported to boston scientific corporation that a solyx sis system device was used during a sling for incontinence procedure for treatment of stress urinary incontinence.According to the complainant, during the procedure, the device would not deploy inside the patient.The procedure was completed with another solyx sis system device.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be good.Additional information received on august 18, 2020.Per medwatch report, it was reported that the mesh carrier did not deply on the sling when placed.The original type of procedure was urethropexy: sling with cystoscopy.It was also reported that the incident occurred on (b)(6) 2020.

Manufacturer Narrative

Additional information: blocks b3 (below), b5 and e4, and h10 (below) have been updated due to additional information from medwatch report.Block b3 date of event: additional information received from the customer stating that the event occurred on (b)(6) 2020; therefore, date of event was approximated to on (b)(6) 2020.Block h6: device code 1158 captures the reportable event of device would not deploy.Block h10: the voluntary user medwatch number is (b)(4).One solyx mesh assembly and one solyx delivery device were received.Visual examination found that the device had signs of use.There was residue / debris on the mesh assembly.One end of the mesh material appeared to have been stretched.There was a damage to the deployment mechanism on the delivery device.It was slightly accordioned, as though it had been compressed.A functional test was performed.Each carrier was loaded onto and deployed from the returned delivery device.Both carriers were released from the device with no issue.A device history record review was performed and found that there were no deviation during the manufacturing of the device lot that would have contributed to the reported event.Based on the damaged to the returned device, it is likely that procedural factors, including procedural debris in the dissection pathway during advancement, could have interfered with the device advancement and deployment and contributed user having difficulty during deployment and subsequently damaging the delivery device and mesh material; confirming the reported complaint.Therefore, the most probable cause for this event is adverse event related to procedure, which indicates that the adverse event occurred during the procedure and the device had no influence on 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
• MDR Report Key: 10274048
• MDR Text Key: 199698633
• Report Number: 3005099803-2020-02613
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729774044
• UDI-Public: 08714729774044
• Combination Product (y/n): N
• PMA/PMN Number: K081275
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 09/16/2020

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: 01/15/2023
• Device Model Number: M0068507000
• Device Catalogue Number: 850-700
• Device Lot Number: 0025051954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/14/2020
• Supplement Dates Manufacturer Received: 08/18/2020
• Supplement Dates FDA Received: 09/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1