BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROTALINK? PLUS

    MDR report key: 3100275 · Received May 8, 2013

    Report

    Report Number
    2134265-2013-03116
    Event Type
    Malfunction
    Date Received
    May 8, 2013
    Date of Event
    January 17, 2013
    Report Date
    April 9, 2013
    Product Code
    MCX
    PMA / PMN Number
    P900056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    RI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). (B)(6).

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED: SAME CASE AS MDR# 2134265-2013-04660. THE PHYSICIAN NOTICED A SMALL RADIOPAQUE "DOT" IN THE APICAL PORTION OF THE MID LAD, PRESUMED TO BE THE BUSHING (LITTLE BUMP ON THE END OF THE ROTAWIRE TO KEEP THE BURR FROM EMBOLIZING PAST THE END OF THE ROTAWIRE) DIRECTLY AFTER THE USE OF THE 1.25MM ROTABLATOR BURR. THE STENT USED TO TRAP THE FRACTURED PORTION OF THE ROTAWIRE GUIDEWIRE IN THE MID LAD WAS A NON BSC DES STENT. CORRECTION: ONLY ONE ROTAWIRE GUIDE WIRE WAS FRACTURED DURING THIS PROCEDURE.

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS MDR# 2134265-2013-03117. SAME CASE AS MDR# 2134265-2013-03118. IT WAS REPORTED THAT DURING A ROTATIONAL ATHERECTOMY TREATMENT PROCEDURE, THE ROTAWIRE GUIDE WIRE FRACTURED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY (LAD). THE PHYSICIAN ATTEMPTED ABLATION TWICE WITH A ROTABLATOR ROTALINK PLUS BURR OVER TWO DIFFERENT ROTAWIRE GUIDEWIRES. THE DEVICE WAS REMOVED FROM THE PATIENT WHEN IT WAS NOTICED THERE WERE TWO RADIOPAQUE FOREIGN BODIES IN THE LAD. THE PHYSICIAN TRIED TO SNARE THE OBJECTS BUT WAS UNSUCCESSFUL. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Description of Event or Problem · 1

    IT WAS FURTHER REPORTED THE MID LEFT ANTERIOR DESCENDING ARTERY( LAD) WAS QUITE CALCIFIED. THE PHYSICIAN ADVANCED A 1.5MM ROTABLATOR BURR TO THE LESION BUT WOULD NOT ADVANCE PAST THAT SEGMENT OF THE LAD. SO THE PHYSICIAN ELECTED TO REMOVE THE 1.5MM BURR AND DOWNSIZE TO A 1.25 MM ROTABLATOR BURR. DURING DYNAGLIDE REMOVAL OF THE 1.25 MM BURR (AFTER SUCCESSFULLY PASSING THE BURR THROUGH THE MID LAD SEGMENT), IT WAS NOTED THAT A PORTION OF THE ROTAWIRE GUIDEWIRE WAS LODGED IN THE MID LAD AND A SHORT SEGMENT (APPROXIMATELY 1.5 CM) OF THE RADIOPAQUE PORTION OF THE ROTAWIRE HAD EMBOLIZED DISTALLY TO THE APICAL PORTION OF THE DISTAL LAD. AN ATTEMPT TO REMOVE THE FOREIGN BODIES WITH A 2MM NON BSC SNARE WAS UNSUCCESSFUL, THE RADIOPAQUE PART OF THE WIRE EMBOLIZED TO THE DISTAL APICAL PORTION OF THE LAD. THE VESSEL WAS FAR TOO SMALL TO ACCOMMODATE A SNARE SO IT WAS LEFT IN PLACE. AND THE FRACTURED PORTION OF THE ROTAWIRE IN THE MID LAD WAS EXCLUDED BY A UNKNOWN DES STENT PLACED IN THE MID LAD. THE PATIENT IS DOING WELL POST-PROCEDURE AND HAS HAD NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    201962 ROTALINK? PLUS CATHETER, CORONARY, ATHERECTOMY MCX H749236310020 0015390233

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR