MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX?; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M0061453620
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a020503 captures the reportable event of unsealed device packaging.
Event or Problem Description
It was reported that a percuflex ureteral stent was to be used in a flexible ureteroscopic lithotripsy and stone extraction with postoperative stent placement.During unpacking it was found that the packaging was opened and found to be damaged.Due to the compromised integrity of the packaging, contamination of the device was suspected.The device was therefore deemed unsuitable for use and was not utilized in the procedure.The procedure was completed with another of the same device.There were no patient complications as a result of this event.

• Brand Name: PERCUFLEX?
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 25552257
• Report Number: 2124215-2026-31991
• Device Sequence Number: 13447137
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: (01)08714729040330(17)280714(10)36972176
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2026

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: M0061453620
• Device Catalogue Number: M0061453620
• Device Lot Number: 0036972176
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/10/2026
• Date Device Manufactured: 07/15/2025
• 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