BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER

    MDR report key: 309886 · Received December 22, 2000

    Report

    Report Number
    2024168-2000-00326
    Event Type
    Injury
    Date Received
    December 22, 2000
    Date of Event
    November 28, 2000
    Report Date
    November 29, 2000
    Manufacturer
    GUIDANT VASCULAR INTERVENTION
    Product Code
    MCX
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ATHERECTOMY PROCEDURE IN THE PROXIMAL LAD, THE NOSECONE WAS OBSERVED TO SEPARATE AFTER 6 CUTS. THE CATHETER WAS WITHDRAWN, BUT THE NOSECONE REMAINED ON THE GUIDE WIRE IN THE LAD. AN EXCHANGE CATHETER WAS USED TO PUSH THE NOSECONE TO A STENOSIS IN THE MID LAD; THE RESTRICTION IN THE VESSEL WAS USED TO HOLD THE NOSECONE IN PLACE WHILE A DILATATION CATHETER WAS PASSED THROUGH THE NOSECONE TIP. THE DILATATION CATHETER WAS INFLATED DISTAL TO THE NOSECONE AND DEFLATED, AND THEN THE ENTIRE SYSTEM WAS REMOVED AS A UNIT. MULTIPLE VESSEL INJURY (DISSECTION) WAS OBSERVED AFTER REMOVAL OF THE DEVICE, AND IT WAS TREATED BY DEPLOYING TWO ADD'L STENTS. THE FIRST DIAGONAL BRANCH WAS PARTIALLY OCCLUDED AFTER DEPLOYMENT OF THE ADD'L STENTS (ANOTHER COMPANY'S DEVICES); SOME FLOW WAS OBSERVED BETWEEN THE STENT COILS. THE PT HAD VENTRICULAR FIBRILLATION AND HAD TO BE RESUSCITATED. THE PT IS REPORTED TO BE DOING FINE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ATHEROCATH-GTO CORONARY ATHERECTOMY CATHETER CORONARY ATHERECTOMY CATHETER MCX GUIDANT VASCULAR INTERVENTION NA 0061252

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention STENT, S670 STENT.| CROSSSAIL 2.5/20 DILATATION CATHETER, S'PORT GUIDE| GUIDING CATHETER, ACS RHV, MEDIKIT LONG SHEATH, ML| WIRE, MEDTRO INFLATION DEVICE, TOURGUIDE SH JCL 4