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

Device Problem Premature Activation (1484)

Patient Problems Tissue Damage (2104); Urinary Retention (2119); No Code Available (3191)

Event Date 08/06/2020

Event Type  Injury  

Manufacturer Narrative

The reported lot number 2900492 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device was discarded and will not be returned for evaluation; therefore, a failure 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 second of two devices used during the same procedure.It was reported to boston scientific corporation that two solyx devices were used during a solyx placement for sui procedure performed on (b)(6) 2020 to treat stress urinary incontinence.According to the complainant, during the initial placement on (b)(6) 2020, the mesh carrier detached from the shaft assembly before the physician could make final tensioning adjustments, and had to forcefully remove the sling which caused tissue damage to the patient.The physician then opened a second solyx device, but the same issue occurred.He then decided to not complete the procedure and leave the sling tensioned a bit tighter than he wanted to decrease tissue trauma of removing and replacing with another sling.The procedure was completed in a revision surgery on (b)(6) 2020 with another solyx device.

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 devices were used during a solyx placement for sui procedure performed on (b)(6), 2020 to treat stress urinary incontinence.According to the complainant, during the initial placement on (b)(6), 2020, the mesh carrier detached from the shaft assembly before the physician could make final tensioning adjustments, and had to forcefully remove the sling which caused tissue damage to the patient.The physician then opened a second solyx device, but the same issue occurred.He then decided to not complete the procedure and leave the sling tensioned a bit tighter than he wanted to decrease tissue trauma of removing and replacing with another sling.The procedure was completed in a revision surgery on (b)(6), 2020 with another solyx device.---additional information received on (b)(6), 2020--- the reason for the revision sugery on (b)(6), 2020 was not just to replace the sling but due to the patient's adverse event of retention after the second sling was left in place.

Manufacturer Narrative

Additional information: blocks b5 and h6 have been updated based on the clarification received from the customer.Blocks d4, h4: the reported lot number 2900492 does not provide a match in the system search; therefore, the device manufacture and expiration dates cannot be determined.However, the complainant reported that the device was not expired.Block h6: patient codes 2119 and 3191 capture the reportable events of urinary retention and revision surgery.Device code 1484 captures the reportable event of unintended release of mesh carrier from shaft assembly.Block h10: the complainant indicated that the device was dicarded and will not be returned for evaluation; therefore, a failure 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
• MDR Report Key: 10615396
• MDR Text Key: 209562071
• Report Number: 3005099803-2020-04256
• Device Sequence Number: 1
• Product Code: PAH
• 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: 10/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 59 YR