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

Model Number	M0061752620
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a010402 captures the reportable event of stent migration.
Event or Problem Description
It was reported that a percuflex plus stent was implanted into the patient.A planned stent removal procedure was then performed to explant the stent.During this procedure, it was found that the stent migrated into the ureter.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: device code a010402 captures the reportable event of stent migration.This event was previously reported.See mfr.Report # 2124215-2025-15174.Upon further review, it was found that this case had been previously reported for the same device, event, health care facility, upn and lot number.Confirmation was received indicating this event is a duplicate to the event filed with an internal references of (b)(4).Based on all the available information, all pertinent information was already reported therefore, boston scientific no longer considers this to be a reportable incident.
Event or Problem Description
It was reported that a percuflex plus stent was implanted into the patient.A planned stent removal procedure was then performed to explant the stent.During this procedure, it was found that the stent migrated into the ureter.There were no patient complications reported as a result of this event.

• 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: 21600913
• Report Number: 2124215-2025-15159
• Device Sequence Number: 9170160
• Product Code: FAD
• UDI-Device Identifier: 08714729056829
• UDI-Public: 08714729056829
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2025
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/19/2025

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: M0061752620
• Device Catalogue Number: 175-262
• Device Lot Number: 0034483980
• 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: 02/18/2025
• Supplement Date Received by Manufacturer: 04/25/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/19/2025
• Date Device Manufactured: 07/22/2024
• 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 Sex: Unknown