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

Model Number	M0061752630
Medical Device Problem Codes	Calcified (1077); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: device code a040501 captures the reportable event of stent calcified.Device code a150207 captures the reportable event of stent difficult to remove.Impact code f23 captures the reportable event of unexpected medical intervention.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was implanted during a stent replacement procedure.On (b)(6) 2024, a lithotripsy for stent removal was performed, and, during this procedure, it was found that stones were attached on the walls of both tubes and could not be removed.A holmium laser lithotripsy under general anesthesia was performed to remove the implanted stent which increased the patient's expenses and treatment.There was no information if a new stent was placed.There were no patient complications reported.
Event or Problem Description
It was reported that a percuflex plus ureteral stent was implanted during a stent replacement procedure on (b)(6) 2024.On (b)(6) 2024, a lithotripsy for a planned stent removal procedure was performed, and, during this procedure, it was found that stones were attached on the walls of both tubes and could not be removed.A holmium laser lithotripsy under general anesthesia was performed to remove the entire stent which increased the patient's expenses and treatment.A new percuflex plus was then implanted to the patient which successfully completed the procedure.There were no patient complications reported and the condition of the patient after the procedure was reported to be good.
Additional Manufacturer Narrative
Block h6: device code a040501 captures the reportable event of stent calcified.Device code a150207 captures the reportable event of stent difficult to remove.Impact code f23 captures the reportable event of unexpected medical intervention.Block b5 has been updated based on the additional information received on january 14, 2025.Corrected blocks a1, a4, e1, e3, and g2 based on the additional information received.

• 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: 21123778
• Report Number: 2124215-2024-83177
• Device Sequence Number: 18326166
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: 08714729041184
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 02/05/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2024
• Device Model Number: M0061752630
• Device Catalogue Number: M0061752630
• Device Lot Number: 0027977713
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/05/2025
• Date Device Manufactured: 09/07/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 60 KG