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

Model Number	M0061453520
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported that a percuflex ureteral stent was to be used in a lithotripsy for right renal stone procedure.During unpacking, it was found that the inner packaging was not sealed and could not meet the sterile conditions.The procedure was completed with another same device and there were no patient complications reported.
Additional Manufacturer Narrative
Block h6: device code a020503 captures the reportable event of packaging seal compromised.Upon receipt at our quality assurance laboratory, this percuflex ureteral stent underwent a thorough analysis.Visual inspection of the device did not reveal any damages.However, the reported event was not confirmed because the inner bag should not be worn since it is inside the pouch that holds the sterile device.The suture, the positioner and the pouch were also returned for analysis.A review of the device history record (dhr) indicated that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the information available, device/media analysis, and analysis results, the reported allegation could not be confirmed.A conclusion code of no problem detected was assigned to this investigation.
Event or Problem Description
It was reported that a percuflex ureteral stent was to be used in a lithotripsy for right renal stone procedure.During unpacking, it was found that the inner packaging was not sealed and could not meet the sterile conditions.The procedure was completed with another same device and there were no patient complications reported.

• 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: 22681356
• Report Number: 2124215-2025-50373
• Device Sequence Number: 8937575
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)270708(10)34386010
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2025

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: M0061453520
• Device Catalogue Number: 145-352
• Device Lot Number: 0034386010
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 08/21/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/08/2024
• 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: 49 YR
• Patient Sex: Male
• Patient Weight: 75 KG