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

Model Number	M0061752720
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: impact device code a0401 captures the reportable event of stent shaft break.
Event or Problem Description
It was reported that, during preparation for a lithotripsy procedure a percuflex plus ureteral stent was used, it was noticed the stent was broken off.The procedure was completed using an alternative device.No patient complications were reported.This report is one of two complaints that pertain to the same event (mfr.Report# 2124215-2024-50426).
Event or Problem Description
It was reported that, during preparation for a lithotripsy procedure a percuflex plus ureteral stent was used, it was noticed the stent was broken off.The procedure was completed using an alternative device.No patient complications were reported.
Additional Manufacturer Narrative
Block h6: impact device code a0401 captures the reportable event of stent shaft break.Block h11: correction: the event reported under mfr report # 2124215-2024-50426 was sent in error.Additional information was received from the complainant, reported that only one stent was used in the procedure.Therefore, mfr.Report # 2124215-2024-50427 will address the reported malfunction of stent kinked.

• 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: 19987528
• Report Number: 2124215-2024-50427
• Device Sequence Number: 12541516
• Product Code: FAD
• UDI-Device Identifier: 08714729056836
• UDI-Public: 08714729056836
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2024

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: M0061752720
• Device Catalogue Number: 175-272
• Device Lot Number: 0033782224
• 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: 07/19/2024
• Supplement Date Received by Manufacturer: 10/09/2024
• Initial Report FDA Received Date: 08/14/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/08/2024
• 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: Male