BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK¿ PLUS

    MDR report key: 2880031 · Received December 19, 2012

    Report

    Report Number
    2134265-2012-08073
    Event Type
    Malfunction
    Date Received
    December 19, 2012
    Date of Event
    November 22, 2012
    Report Date
    November 29, 2012
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER EXAMINATION OF THE RETURNED DEVICE REVEALED THE CATHETER SHEATH WAS DAMAGED/SPLIT APPROXIMATELY 21.5CM AND 22.2CM FROM THE STRAIN RELIEF. INITIAL EXAMINATION OF THE COMPLAINT ROTABLATOR PLUS UNIT REVEALED NO ADDITIONAL VISUAL ISSUES. A TUG TEST WAS PERFORMED TO EXAMINE THE INTEGRITY OF THE CONNECTION. A CONNECT/DISCONNECT TEST WAS CARRIED OUT. NO ISSUES WERE NOTED WITH THE UNIT HANDSHAKE CONNECTORS. AN ATTEMPT WAS MADE TO WET TEST THE DEVICE. IT WAS NOTED APPROXIMATELY 21.5CM FROM THE STRAIN RELIEF; THE SHEATH WAS LEAKING. A PIN HOLE WAS EVIDENT. THE CATHETER COULD NOT BE WET TESTED DUE TO THE DAMAGE TO THE CATHETER SHEATH. THIS IS CONSISTENT WITH OVER TIGHTENING OF THE HEMOSTASIS VALVE. THE MANUFACTURING BATCH RECORD REVIEW CONFIRMED THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATION. THE MOST PROBABLE ROOT CAUSE IS USE RELATED ISSUES. THE DFU STATES "IF THE HEMOSTASIS VALVE IS TIGHTENED EXCESSIVELY, IT CAN CRUSH THE SHEATH AROUND THE DRIVE SHAFT AND CAUSE PERMANENT DAMAGE TO THE ROTALINK CATHETER. THE HEMOSTASIS VALVE SHOULD BE CLOSED JUST TIGHT ENOUGH TO PREVENT BLOOD LOSS, BUT STILL ALLOW THE ROTALINK SHEATH TO SLIDE THROUGH THE VALVE.' (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATED BY MANUFACTURER: 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 REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A HOLE IN THE SHEATH WAS NOTED. THE LESION LOCATION WAS UNSPECIFIED. DURING ABLATION, IT WAS OBSERVED THAT A HOLE WAS PRESENT ON THE SHEATH OF THE 1.50MM ROTABLATOR ROTALINK PLUS. THE HOLE WAS NOTED TO BE DEVICE OUTSIDE OF THE PATIENT BODY, AT THE GROIN. ROTAGLIDE WAS LEAKING OUT OF THE HOLE, AND IT WAS NOTED THAT THE RPM'S WERE REDUCED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, A HOLE IN THE SHEATH WAS NOTED. THE LESION LOCATION WAS UNSPECIFIED. DURING ABLATION, IT WAS OBSERVED THAT A HOLE WAS PRESENT ON THE SHEATH OF THE 1.50MM ROTABLATOR ROTALINK PLUS. THE HOLE WAS NOTED TO BE DEVICE OUTSIDE OF THE PATIENT BODY, AT THE GROIN. ROTAGLIDE WAS LEAKING OUT OF THE HOLE AND IT WAS NOTED THAT THE RPM'S WERE REDUCED. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT STATUS IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ROTALINK¿ PLUS CATHETER, CORONARY, ATHERECTOMY MCX BOSTON SCIENTIFIC - CORK H749236310030 15536624

    Patients

    Seq Age Sex Outcome Treatment
    1