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

Model Number	M0061752630
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that during unpacking, it was found that the device was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Correction to block h6 device code.Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block h11: the percuflex plus ureteral stent was not returned for analysis, but media analysis was performed, and it was observed that the bladder coil fully detached which confirms the reported event of coil detachment of device or device component.It is most likely the retrieval line gets entangled in the bladder coil when it is being removed, the stent can get detached during the preparation and based on the media provided, the suture was not visibly assembled in the device indicating it might have been removed.The removal of the suture may have contributed to the detachment of the bladder coil.A conclusion code of adverse event related to procedure was assigned to this investigation.Furthermore, it should be noted that the data reasonably suggest that this event (coil detachment, outside the patient, and during unpacking) is anticipated in nature and severity.The manufacturer has reviewed all information and determined this event no longer meets reporting criteria for the device in question.
Event or Problem Description
It was reported that during unpacking, it was found that the device was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.
Additional Manufacturer Narrative
Block h11: the percuflex plus ureteral stent was returned for analysis with the pouch and the positioner for analysis.However, the suture did not return.During the inspection it was found that the stent bladder coil totally detached.Although this can result in a clinically insignificant delay of the procedure, this event is unlikely to cause or contribute to a death or serious injury if the malfunction were to recur.Therefore, boston scientific no longer considers this to be a reportable event.Block h6 has been updated based on the additional information received on june 03, 2025.
Event or Problem Description
It was reported that during unpacking, it was found that the device was fractured.The procedure was completed with another of the same device and the patient condition following procedure was stable.

• 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: 22146812
• Report Number: 2124215-2025-36109
• Device Sequence Number: 15406893
• Product Code: FAD
• UDI-Device Identifier: 08714729041184
• UDI-Public: (01)08714729041184(17)270304(10)33556675
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K924608
• 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,Followup
• Report Date (Section B): 08/05/2025

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: M0061752630
• Device Catalogue Number: M0061752630
• Device Lot Number: 0033556675
• 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: 05/13/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/12/2025
• Initial Report FDA Received Date: 06/04/2025
• Supplement Report FDA Received Date: 06/25/2025; 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/04/2024
• 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: 40 YR
• Patient Sex: Male
• Patient Weight: 60 KG