BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 3910316 · Received July 2, 2014

    Report

    Report Number
    2183870-2014-00162
    Event Type
    Injury
    Date Received
    July 2, 2014
    Date of Event
    June 2, 2014
    Report Date
    June 3, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K111010
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE COULD NOT BE CONDUCTED BECAUSE THE LOT NUMBER WAS NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    THIS MDR IS BEING SUBMITTED AS A PART OF A RETROSPECTIVE REVIEW / REMEDIATION EFFORT PERFORMED AT THE COVIDIEN PLYMOUTH LOCATION, FOLLOWING MEDTRONIC¿S ACQUISITION OF COVIDIEN.  A CAPA HAS BEEN OPENED TO MANAGE THE ACTIONS RELATED TO REMEDIATION OF COMPLAINT FILES AND ANY REQUIRED MDR REPORTING.

    Description of Event or Problem · 1

    THE PHYSICIAN ENTERED VIA THE LEFT FEMORAL TO TREAT THE RIGHT TPT. THE PHYSICIAN CROSSED THE LESION WITH A 4.0 SPIDERFX, AND PREDILATED WITH A 3.0 X 15MM CORONARY BALLOON. THE PHYSICIAN THEN INSERTED THE TURBOHAWK, BUT ONLY PART OF THE DISTAL TIP WAS ABLE TO CROSS THE LESION. THE PHYSICIAN ATTEMPTED TO REMOVE THE TURBOHAWK, BUT IT COULD NOT ENTER THE DISTAL END OF THE SHEATH. AT ONE POINT A LOOP FORMATION OF THE SPIDERFX WIRE NEAR THE SHEATH WAS OBSERVED, BUT IT NEVER FRACTURED OR SEPARATED FROM THE FILTER. THE PHYSICIAN THEN ATTEMPTED TO PULL THE SHEATH, SPIDER WIRE AND TURBOHAWK OUT AT THE SAME TIME, BUT THE TURBOHAWK WAS CAUGHT UP WITHIN THE SHEATH. ADDITIONAL FORCE WAS USED, AND THE TURBOHAWK CAME OUT, BUT IT WAS OBSERVED THAT THE TURBOHAWK NOSECONE STAYED INSIDE THE SHEATH BECAUSE IT HAD SEPARATED FROM THE REST OF THE DEVICE. A VASCULAR SURGEON WAS CONSULTED AND THE PATIENT WAS BROUGHT UP TO THE OR TO HAVE A CUT DOWN PERFORMED TO REMOVE THE SPIDER, TURBOHAWK NOSECONE, AND SHEATH. PLEASE REFERENCE MDR 2183870-2014-00161 FOR THE TURBOHAWK USED IN THIS PROCEDURE.

    Description of Event or Problem · 1

    THE TIP ASSEMBLY PIECE WAS THREADED OVER THE CAPTURE WIRE CORE. THE CAPTURE WIRE EXHIBITED A SEVERE BEND AND A 360 DEGREES COILING PROXIMAL TO THE TIP ASSEMBLY PIECE. THE DISTAL TIP ASSEMBLY EXHIBITED A SIGNIFICANT BEND AND THE GUIDEWIRE LUMEN WAS TORN LONGITUDINALLY ALONG THE ENTIRE LENGTH OF THE TIP ASSEMBLY BODY AND INTO THE ROTATING (TAPERED) SECTION OF THE TIP ASSEMBLY. SIMILAR DAMAGE TO BOTH THE CAPTURE WIRE AND THE TURBOHAWK TIP ASSEMBLY HAS BEEN OBSERVES WHEN THE CAPTURE WIRE IS PROLAPSED OR WRAPPED AROUND THE DEVICE PROXIMAL TO THE TURBOHAWK'S RX WIRE LUMEN AND THE DEVICE IS THEN PULLED INTO THE GUIDE SHEATH THIS CAUSES THE CAPTURE WIRE TO TEAR THE RX LUMEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    386306 SPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN SPD2-US-040-320 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention 6F DESTINATION SHEATH 45CM| 3.0 X 15 MM ABBOTT TREK CORONARY BALLOON