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

Model Number	M0068502160
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block g4: the premarket / 510(k) #s are k211223 & k231549.Block h6: device code a020503 captures the reportable event of seal compromised.
Event or Problem Description
It was reported that an advantage fit ultra system device upon receipt was reported as damaged.The healthcare facility provided photographic evidence showing dents on the device packaging, along with cracking and breakage of the plastic blister tray prior to use.No patient involvement was reported, and the device was not used in a clinical procedure.
Additional Manufacturer Narrative
Block g4: the premarket / 510(k) #s are k211223 & k231549.Block h6: device code a020503 captures the reportable event of seal compromised.Block h11: with all the available information, bsc concludes that the reported allegation of the packaging sealed compromise was confirmed through product analysis.Visual inspection of the returned unused device without the packaging did not reveal any damages, but images provided by the customer showed that the package was dented and the inner tray was broken.A dhr review confirmed that the devices met all material, assembly, and performance specifications.A review was completed and confirmed that the event of packaging sealed compromised was defined in the risk documentation.This event type has been accounted for during analysis to support acceptable risk benefit for the product.A review of the device instructions for use (ifu) was completed and the ifu cited: "the devices are packaged in a tray sealed with a lid which acts as a sterile barrier.Do not use if package is damaged or unintentionally opened before use.".It is likely that the packaging was damaged after manufacturing and packaging, but prior to the customer's use of the device, most likely during transport.Based on the information available, a conclusion code of cause traced to transport/storage was assigned to this investigation, which indicates "problems traced to the inappropriate transport or storage of the device.".
Event or Problem Description
It was reported that an advantage fit ultra system device upon receipt was reported as damaged.The healthcare facility provided photographic evidence showing dents on the device packaging, along with cracking and breakage of the plastic blister tray prior to use.No patient involvement was reported, and the device was not used in a clinical procedure.

• Brand Name: ADVANTAGE FIT ULTRA SYSTEM
• Common Device Name: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RET
• 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: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 24693981
• Report Number: 2124215-2026-16471
• Device Sequence Number: 10557262
• Product Code: OTN
• UDI-Device Identifier: 00191506007669
• UDI-Public: (01)00191506007669(17)281026(10)37806486
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K211223
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2026

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
• Operator of Device: Health Professional
• Device Model Number: M0068502160
• Device Catalogue Number: M0068502160
• Device Lot Number: 0037806486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/02/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/27/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown