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

Model Number M0068507010

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Incontinence (1928); No Code Available (3191)

Event Date 10/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).The complainant indicated that the removed sling was disposed 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

It was reported to boston scientific corporation that a solyx blue sis system was implanted during a single incision sling procedure performed on (b)(6) 2019.According to the complainant, post procedure, the patient experienced more bladder leakage than she had before.On (b)(6) 2019, a revision was performed by removing the solyx sling from the original surgery and was replaced with a lynx sling.There were no patient complications noted after the revision.

Manufacturer Narrative

Additional information - blocks b5 updated.Blocks h6: patient code of 3191 captures the reportable event of surgery performed to remove the device from the patient.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the complainant indicated that the removed sling was disposed 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 pertains to the first of two devices implanted into the patient during two different procedures.It was reported to boston scientific corporation that a solyx blue sis system was implanted during a single incision sling procedure performed on (b)(6) 2019.According to the complainant, post procedure, the patient experienced more bladder leakage than she had before.On (b)(6)2019, a revision was performed by removing the solyx sling from the original surgery and was replaced with a lynx sling.There were no patient complications noted after the revision.On (b)(6) 2019, the patient returned to the physician because the patient developed incomplete bladder emptying with straining to void which required a self-catheterization.On the same day, the physician incised the lynx sling.During the patient's follow-up visit after the sling incision, the patient is reportedly still experiencing leaking more than before.Reportedly, the physician will be referring the patient to another physician.

• 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: 9317597
• MDR Text Key: 166226357
• Report Number: 3005099803-2019-05499
• Device Sequence Number: 1
• Product Code: PAH
• UDI-Device Identifier: 08714729961901
• UDI-Public: 08714729961901
• 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: 02/10/2020

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 Expiration Date: 03/05/2022
• Device Model Number: M0068507010
• Device Lot Number: 0023446303
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2019
• Initial Date FDA Received: 11/13/2019
• Supplement Dates Manufacturer Received: 01/14/2020
• Supplement Dates FDA Received: 02/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR