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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019, implant date, as no event date was reported.This event was reported by the patient's legal representation.The implant surgeon is: (b)(6); australia.(b)(4).The complaint device is not expected to be returned for evaluation; therefore, a problem 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 was used during a midureteral advantage sling and cystoscopy procedures performed on (b)(6) 2019 to treat a patient with stress urinary incontinence.As reported by the patient's attorney, the patient experienced an unknown injury.

• 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
• 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: 15156736
• Report Number: 3005099803-2022-03901
• Device Sequence Number: 5395346
• Product Code: OTN
• UDI-Device Identifier: 08714729961918
• UDI-Public: 08714729961918
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K020110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/03/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 10/05/2020
• Device Model Number: M0068502050
• Device Catalogue Number: 73184
• Device Lot Number: 0021223513
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/07/2022
• Initial Report FDA Received Date: 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2017
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female