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

Model Number	M0061453620
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of stent shaft break.The implant date was in (b)(6) 2024.
Event or Problem Description
It was reported that, during the kidney stone surgery a percuflex ureteral stent was going to be used.When the physician unpacked the device, it was found that the stent was fractured.Another ureteral stent package was opened, and it was fractured again.The procedure was completed with another of the same device.No patient complications were reported.This report is one of two complaints that pertain to the same event (mfr report # 2124215-2024_71116 and mfr report # 2124215-2024-71119).
Event or Problem Description
It was reported that, during the kidney stone surgery a percuflex ureteral stent was going to be used.When the physician unpacked the device, it was found that the stent was fractured.Another ureteral stent package was opened, and it was fractured again.The procedure was completed with another of the same device.No patient complications were reported.This report is one of two complaints that pertain to the same event (mfr report # 2124215-2024-71116 and mfr report # 2124215-2024-71119).
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.Block d6a: the implant date was in (b)(6) 2024.Block h11: the returned percuflex stent was analyzed, and a visual evaluation noted during the inspection, the stent shaft detached/separated into three pieces.The device was inspected under magnification, and it was possible to see that some drainage holes are stretched and deformed.It is possible to conclude that this problem could be caused by operational factors.Furthermore, there was evidence that force was applied to the device causing the detachment of the stent into three sections and probably the tension submitted caused the deformation and stretch of the drainage holes.The retrieval line may be removed before placement at the physician's discretion.If the retrieval line gets entangled in the stent and is removed using excess force, the stent could be detached/separated during the preparation affecting the performance of the device.Based on the analysis results of observed, an investigation conclusion code of adverse event related to procedure was assigned to this investigation.

• 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: 20717891
• Report Number: 2124215-2024-71116
• Device Sequence Number: 15498938
• Product Code: FAD
• UDI-Device Identifier: 08714729040330
• UDI-Public: 08714729040330
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K834468
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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
• Report Date (Section B): 01/08/2025

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: M0061453620
• Device Catalogue Number: M0061453620
• Device Lot Number: 0033742932
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 11/19/2024
• Supplement Report FDA Received Date: 01/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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: Female