BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM

    MDR report key: 3830069 · Received May 23, 2014

    Report

    Report Number
    3004742232-2014-00024
    Event Type
    Injury
    Date Received
    May 23, 2014
    Date of Event
    April 28, 2014
    Report Date
    May 7, 2014
    Manufacturer
    CARDIOVASCULAR SYSTEMS INCORPORATED
    Product Code
    MCW
    PMA / PMN Number
    K133399
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS. THE OAD WAS RETURNED WITH THE DETACHED SALINE SHEATH AND DRIVESHAFT. TWO VIPERWIRE GUIDE WIRES WERE RETURNED, ONE OF WHICH WAS ENGAGED IN THE DETACHED DRIVESHAFT SECTION. THE INITIAL VISUAL AND TACTILE EXAMINATION OF THE HANDLE ASSEMBLY REVEALED THAT THE SALINE SHEATH AND DRIVESHAFT HAD BEEN DESTRUCTIVELY CUT FROM THE HANDLE ASSEMBLY AT THE DISTAL END OF THE HANDLE. EXAMINATION OF THE DRIVESHAFT SECTION REVEALED THAT THE DRIVESHAFT AND CROWN SECTION HAD BEEN CUT AND DETACHED. THE DETACHED SECTION WAS NOT RETURNED FOR ANALYSIS. IT COULD NOT BE DETERMINED WHETHER THE CROWN OR DRIVESHAFT SECTION WERE DAMAGED OR IF THEY CONTRIBUTED TO THE DIFFICULTIES EXPERIENCED DURING THE PROCEDURE. THE DRIVESHAFT FILARS WERE SEVERELY STRETCHED AND ELONGATED. IT WAS FURTHER DISCOVERED THAT THE GUIDE WIRE WAS ENGAGED WITHIN THE DRIVESHAFT. THE DAMAGE IS CONSISTENT WITH ATTEMPTING TO REMOVE THE DRIVESHAFT SECTION FROM THE PATIENT AS REPORTED. THE GUIDE WIRE SPRING TIP COULD BE SEEN WITHIN THE STRETCHED FILARS. IT APPEARS THAT THE GUIDE WIRE WAS USED TO AID IN THE REMOVAL OF THE DRIVESHAFT SECTION FROM THE PATIENT AS STATED IN THE EVENT DESCRIPTION. THE GUIDE WIRE SPRING TIP AND PROXIMAL SOLDER BOND REMAINED INTACT AND UNDAMAGED. THE INITIAL VISUAL EXAMINATION OF THE GUIDE WIRE (USED INITIALLY) REVEALED THAT IT HAD BEEN DESTRUCTIVELY CUT 183.5CM PROXIMAL TO THE DISTAL END OF THE SPRING TIP. THE GUIDE WIRE ALSO EXHIBITED BENDS AND KINKS ALONG THE SHAFT. THE PROXIMAL SPRING TIP SOLDER BOND EXHIBITED DAMAGE CONSISTENT WITH THE SPRING TIP HAVING BEEN PULLED OUT PROXIMALLY FROM THE DETACHED DRIVESHAFT SECTION. THE GUIDE WIRE SECTION WAS SENT FOR SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS. SEM ANALYSIS CONFIRMED DAMAGE CONSISTENT WITH REMOVING THE GUIDE WIRE PROXIMALLY THROUGH THE DRIVESHAFT. AT THE CONCLUSION OF THE FAILURE ANALYSIS INVESTIGATION, THE ROOT CAUSE OF THE DEVICE GETTING STUCK IN THE PATIENT COULD NOT BE DETERMINED. THE DEVICE HISTORY RECORD FOR THIS OAD LOT NUMBER HAS BEEN REVIEWED. NO ISSUES OR DISCREPANCIES WERE NOTED DURING THIS REVIEW THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE DEVICE MET MATERIAL, ASSEMBLY, AND QUALITY CONTROL REQUIREMENTS. THE MATERIAL INSPECTION REPORT FOR THE VIPERWIRE GUIDE WIRES WAS NOT REVIEWED AS THE LOT NUMBERS ARE UNKNOWN. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PERIPHERAL ORBITAL ATHERECTOMY PROCEDURE, A CSI ORBITAL ATHERECTOMY DEVICE (OAD) GOT STUCK IN THE PATIENT AND REQUIRED ADDITIONAL INTERVENTION. THERE WERE MULTIPLE FOCAL LESIONS LOCATED IN THE TIBIOPERONEAL TRUNK (TPT), PERONEAL AND POSTERIOR TIBIALIS (PT) ARTERIES. THE PHYSICIAN USED A 6FR INTRODUCER SHEATH FROM A CONTRALATERAL APPROACH TO ACCESS THE LESIONS. THE PHYSICIAN SUCCESSFULLY TREATED THE PROXIMAL PERONEAL ARTERY USING THE CSI OAD AND VIPERWIRE GUIDE WIRE. DURING TREATMENT IN THE DISTAL PERONEAL ARTERY, THE DEVICE BECAME STUCK IN THE PATIENT. THE DRIVESHAFT WAS CUT AND THE PATIENT WAS TRANSFERRED TO DEL SOL MEDICAL CENTER FOR REMOVAL OF THE DEVICE. THE SURGEON ADVISED TO REMOVE THE DEVICE MECHANICALLY BY ADVANCING A SHEATH OVER THE DRIVESHAFT. A 7FR INTRODUCER SHEATH WAS ADVANCED OVER THE DRIVESHAFT AND INTO THE PATIENT TO ACCESS THE STUCK DRIVESHAFT. A FRONTRUNNER MICROGLIDE CATHETER (140CM) WAS THEN ADVANCED OVER THE DRIVESHAFT, INTO THE INTRODUCER SHEATH AND INTO THE DISTAL PERONEAL ARTERY. A SECOND GUIDE WIRE WAS LOADED INTO THE PATIENT AND USED TO AID IN THE REMOVAL OF THE DEVICE. THE MICROGLIDE CATHETER WAS ADVANCED OVER THE DRIVESHAFT AND CROWN AND THE SURGEON WAS ABLE TO FREE THE DRIVESHAFT; HOWEVER, THE DISTAL TIP OF THE DRIVESHAFT FRACTURED AND WAS LEFT IN THE DISTAL PERONEAL ARTERY. ANGIOGRAPHY REVEALED ADEQUATE FLOW INTO THE DISTAL PERONEAL ARTERY. BLOOD CLOTS WERE DISCOVERED IN THE TPT, BUT WERE REMOVED USING A QUICK-CROSS CATHETER. THE PATIENT STATUS REMAINED STABLE THROUGHOUT THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    308758 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM PERIPHERAL ATHERECTOMY DEVICE MCW CARDIOVASCULAR SYSTEMS INCORPORATED DBP-125MICRO145 98626

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention