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

Model Number	M0061752530
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: initial reporter facility name, and initial reporter address 2 (b)(6).Block h6: device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a catheterization procedure.During unpacking, it was found that the seal of the packaging was damaged.The procedure was completed of another of the same device and there were no patient complications reported.
Additional Manufacturer Narrative
(b)(6).Device code a020503 captures the reportable event of packaging seal compromised.Investigation analysis: upon receipt at our quality assurance laboratory, this percuflex plus underwent a thorough analysis.Visual analysis did not identify any damages to the returned device.The pouch was also returned.A photo was provided showed the pouch, but the issue was not clear on the image provided; for this reason and due to the lack of evidence is unable to confirm the reported event.A review of the device history record (dhr) was performed.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.A risk review was completed and confirmed that the event of packaging seal compromised was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on the information available and analysis results, the reported allegations could not be confirmed.A conclusion code of cause not established was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was to be used in a catheterization procedure.During unpacking, it was found that the seal of the packaging was damaged.The procedure was completed of another of the same device and there were no patient complications reported.

• Brand Name: PERCUFLEX PLUS
• 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: 24127497
• Report Number: 2124215-2026-03782
• Device Sequence Number: 10394519
• Product Code: FAD
• UDI-Device Identifier: 08714729056812
• UDI-Public: (01)08714729056812(17)280408(10)36267521
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2026

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: M0061752530
• Device Catalogue Number: 175-253
• Device Lot Number: 0036267521
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/23/2025
• Supplement Date Received by Manufacturer: 05/08/2026
• Initial Report FDA Received Date: 01/21/2026
• Supplement Report FDA Received Date: 06/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2025
• 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 Age: 54 YR
• Patient Sex: Male
• Patient Weight: 70 KG