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

Model Number	M0061453520
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, when the ureteral stent was prepared to place, the nurse unpacked it for the physician.When the physician inserted the ureteral stent into the zebra guidewire, it was found damaged at the tail end of the ureteral stent and immediately informed the nurse to replace it.After the ureteral stent was replaced, the procedure proceeded smoothly and the patient's condition was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of coil detachment of device or device component, inside the patient.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil detachment of device or device component, inside the patient.Block h11: the percuflex plus ureteral stent was not returned for analysis, however the customer provided media of the device.The reported event of coil detachment will not be confirmed.During media inspection, it showed a percuflex with the suture hole torn.Analysis of the evidence provided by the customer it was found the suture hole torn.Also, the suture was not visible indicating it was removed from the device.It is possible to conclude that this issue could be caused by operational factors.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line is removed using excess force, the stent can get torn during the procedure affecting the performance of the device.For that reason, the issue found of "suture hole torn" will be documented as "adverse event related to procedure".
Event or Problem Description
It was reported that during the procedure, when the ureteral stent was prepared to place, the nurse unpacked it for the physician.When the physician inserted the ureteral stent into the zebra guidewire, it was found damaged at the tail end of the ureteral stent and immediately informed the nurse to replace it.After the ureteral stent was replaced, the procedure proceeded smoothly and the patient's condition was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation results of coil detachment of device or device component, inside the patient.Correction to block b5.Correction to block e1 initial reporter title and e3 occupation.The percuflex ureteral stent coil was clarified to be torn that occurred outside the patient.Therefore, this determined that the event no longer meets reporting criteria.This event is now considered non reportable.
Event or Problem Description
It was reported that during the transurethral ureteroscopy with ureteral holmium laser lithotripsy and ureteral stent placement procedure, when the percuflex ureteral stent was prepared to place, the nurse unpacked it for the physician.When the physician inserted the ureteral stent into the zebra guidewire, it was found damaged at the tail end of the ureteral stent and immediately informed the nurse to replace it.After the ureteral stent was replaced, the procedure proceeded smoothly and the patient's condition was stable.

• 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: 21981656
• Report Number: 2124215-2025-28620
• Device Sequence Number: 15532039
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: (01)08714729040279(17)270124(10)33285790
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/11/2025

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: 0033285790
• 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: 04/18/2025
• Supplement Date Received by Manufacturer: 05/22/2025; 07/16/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/13/2025; 08/11/2025
• Date Device Manufactured: 01/25/2024
• 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: 68 YR
• Patient Sex: Female