MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANTAGE BLUE SYSTEM; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number	M0068502050
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	Internal Organ Perforation (1987); Obstruction/Occlusion (2422); Urinary Incontinence (4572)
Date of Event	01/07/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported lot number 20408100 does not provide a match in the system search; however, it was reported that the expiration date is november 28, 2022.(b)(4).The complainant indicated that the device was disposed and is not expected to 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 or Problem Description
It was reported to boston scientific corporation that an advantage blue system device was implanted into the patient during a mid-urethral sling placement procedure performed on (b)(6) 2021 to treat stress urinary incontinence.When the patient was leaking urine after the procedure they discovered bladder perforation and removed the mesh on (b)(6) 2021.The patient was then rescheduled for a new mesh implant (advantage blue system) three months later.Prior to the new implant, bladder stone caused by the fragments of the original mesh was discovered via cystoscopy and was removed.Subsequently, the patient had the new mid-urethral sling implanted.Reportedly, the issue has been resolved and the patient's current condition is good.

• Brand Name: ADVANTAGE BLUE SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11778222
• Report Number: 3005099803-2021-02044
• Device Sequence Number: 17055698
• Product Code: OTN
• UDI-Device Identifier: 08714729961918
• UDI-Public: 08714729961918
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/05/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/28/2022
• Device Model Number: M0068502050
• Device Catalogue Number: 73184
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/12/2021
• Initial Report FDA Received Date: 05/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention