BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM

    MDR report key: 1990035 · Received February 15, 2011

    Report

    Report Number
    2134265-2011-00322
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 19, 2011
    Report Date
    January 19, 2011
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: RETURNED PRODUCT ANALYSIS REVEALED THE DEVICE WAS FRACTURED WITH BOTH DISTAL AND PROXIMAL PORTIONS RECEIVED. THE DISTAL END OF THE WIRE IS ATTACHED TO A CATHETER. VISUAL AND TACTILE INSPECTIONS WERE PERFORMED. THE CORE WIRE IS FRACTURED AT APPROXIMATELY 298.7CM FROM THE PROXIMAL END. THE SPRING TIP IS KINKED AT APPROXIMATELY 0.5CM FROM THE DISTAL END. OUTER DIAMETER MEASUREMENTS TAKEN MET SPECIFICATION. SEM ANALYSIS CONCLUDED THE FRACTURE WAS DUE TO A TORSION OVERLOAD. NO MATERIAL ANOMALIES WERE FOUND. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT AS DEVICE PERFORMANCE WAS LIMITED DUE TO ANATOMICAL/PROCEDURAL FACTORS. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4): THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.(B)(4)

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL TIP OF THE GUIDE WIRE DETACHED WHILE INSIDE THE PATIENT AND CAME OUT WITH A BALLOON CATHETER. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THAT THE DISTAL TIP OF THE GUIDE WIRE DETACHED WHILE INSIDE THE PATIENT AND CAME OUT WITH A BALLOON CATHETER. THERE WERE NO DEVICE FRAGMENTS LEFT INSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THE PATIENT'S STATUS IS STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE GUIDE WIRE BROKE. THE TARGET LESION DETAILS ARE UNKNOWN. THE 325CM ROTAWIRE WAS ADVANCED INTO THE PATIENT. THE PHYSICIAN MADE 'RAPID ROTATION MOVEMENTS' IN ORDER TO ADVANCE THE GUIDE WIRE, BUT WAS NOT ABLE TO CROSS THE LESION. "AT WITHDRAWAL, THEY NOTICED THAT THE EXTREMITY OF THE GUIDEWIRE WAS BROKEN ON THE BALLOON CATHETER." THE WERE NO PATIENT COMPLICATIONS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IS NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - COSTA RICA H802228240020

    Patients

    Seq Age Sex Outcome Treatment
    1