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

Model Number	M0061453520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during preparation, when the packaging was opened, the device was found damaged.The procedure was completed with another of the same device.The patient condition following procedure was stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent shaft break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of stent shaft break.The returned percuflex stent was analyzed, during the visual inspection and device inspection using magnification, there is evidence of the stent coil torn where the suture hole torn until the tip.Additionally, the suture did not return indicating that it was removed.The reported event of stent shaft break will not be confirmed.This failure could has caused due to an interaction of the device with the suture string such as entanglement, manipulation or excess of force applied over the device.Consequently, affect the performance of the device.Therefore, all compiled information on this investigation determines that the most probable cause is failure to follow instructions since problems were traced to the user not following the manufacturer's instructions the ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.A review of the manufacturing documentation for this reveled that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported that during preparation, when the packaging was opened, the device was found damaged.The procedure was completed with another of the same device.The patient condition following procedure 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: 21106374
• Report Number: 2124215-2024-82860
• Device Sequence Number: 15649151
• Product Code: FAD
• UDI-Device Identifier: 08714729040279
• UDI-Public: 08714729040279
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2025

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: 0033234377
• 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: 12/12/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/08/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 69 KG