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

Model Number	M0061752540
Medical Device Problem Code	Calcified (1077)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: problem device code a040501 captures the reportable event of stent calcified.Impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported that, during a transurethral lithotomy procedure, a percuflex plus ureteral stent was successfully implanted on (b)(6) 2024.On (b)(6) 2024, it was found that the stent was encrusted, and it was removed from the patient.Another of the same stent was used to replace the encrusted stent.No further patient complications were reported.
Event or Problem Description
It was reported that, during a transurethral lithotomy procedure, a percuflex plus ureteral stent was successfully implanted on (b)(6) 2024.On (b)(6) 2024, it was found that the stent was encrusted, and it was removed from the patient.Another of the same stent was used to replace the encrusted stent.No further patient complications were reported.
Additional Manufacturer Narrative
Block h6: problem device code a040501 captures the reportable event of stent calcified.Impact code f2301 captures the reportable event of additional device required.
Additional Manufacturer Narrative
Block h6: problem device code a040501 captures the reportable event of stent calcified.Impact code f2301 captures the reportable event of additional device required.Block h11: correction to field block b5: describe event or problem.Correction to field: initial reporter phone, initial reporter address 1, and initial reporter address 2.
Event or Problem Description
It was reported that, during a transurethral lithotomy procedure, a percuflex plus ureteral stent was successfully implanted on (b)(6) 2024.After 28 days, it was determined that the stent was encrusted.On (b)(6) 2024, the stent was removed from the patient using a grasper.Another of the same stent was used to replace the encrusted stent.No further patient complications were 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: 19779685
• Report Number: 2124215-2024-43594
• Device Sequence Number: 18210125
• Product Code: FAD
• UDI-Device Identifier: 08714729067757
• UDI-Public: 08714729067757
• Combination Product (Y/N): N
• Initial Reporter Country: IR
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/07/2024

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: 10/03/2025
• Device Model Number: M0061752540
• Device Catalogue Number: 175-254
• Device Lot Number: 0030270604
• 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: 06/26/2024
• Supplement Date Received by Manufacturer: 07/24/2024; 09/11/2024
• Initial Report FDA Received Date: 07/18/2024
• Supplement Report FDA Received Date: 08/21/2024; 10/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/04/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 72 KG