BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPIDERFX EMBOLIC PROTECTION DEVICE

    MDR report key: 4020881 · Received August 19, 2014

    Report

    Report Number
    2183870-2014-00208
    Event Type
    Injury
    Date Received
    August 19, 2014
    Date of Event
    July 21, 2014
    Report Date
    July 23, 2014
    Manufacturer
    COVIDIEN
    Product Code
    NTE
    PMA / PMN Number
    K063204
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE MANUFACTURE RECORDS FOR THIS DEVICE DID NOT REVEAL ANY DISCREPANCIES RELEVANT TO THE REPORTED EVENT.

    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

    THIS PROCEDURE WAS PERFORMED IN (B)(6) AS PART OF THE (B)(4) CLINICAL TRIAL: ENDOVASCULAR THERAPY OF RIGHT SFA STENOSIS USED THE THS-SX-C AND SPD2-060-190 FROM THE LEFT INGUINAL REGION WAS PERFORMED. EXTENSION WAS GOOD. HEMATOMA AND HEMOSTASIS OF THE PUNCTURE SITE WERE NOT GENERATED. BECAUSE OF THE SATISFACTORY PROGRESS, THE SUBJECT WAS DISCHARGED FROM STUDY SITE. ON (B)(6) 2014, THE SUBJECT VISITED THE STUDY SITE FOR A LUMP AT THE PUNCTURE SITE. THE PATIENT HAD CONFIRMED BULGING OF AROUND 3CM, WITH TENDERNESS AT THE LEFT GROIN BY ABDOMINAL CT. THERE WAS NO FEELING OF HEAT AND REDNESS. THE SUBJECT RECEIVED AN INSTRUCTION TO RE-VISIT IT IF THE SYMPTOMS WORSENED. ON (B)(6) 2014, THE SUBJECT RE-VISITED THE STUDY SITE BECAUSE THE BULGING INCREASED AND THE PAIN WAS EXACERBATED. THE SUBJECT RECEIVED AN ECHO WHICH FOUND A HEMATOMA 15MM X 23 MM AND THROMBOSIS WITHIN HEMATOMA. THE SUBJECT WAS CONFIRMED THAT THERE WAS NO PSEUDOANEURYSM. THE SUBJECT RECEIVED AN INSTRUCTION TO RE-VISIT NEXT WEEK. HOWEVER, ON (B)(6) 2014 AN AMBULANCE WAS CALLED FOR THE SUBJECT WHO WAS BLEEDING FROM THE GROIN. BECAUSE INFECTION WAS SUSPECTED, THE SUBJECT WAS ADMITTED TO THE STUDY SITE. THE PATIENT WAS DIAGNOSED WITH A CATHETER PUNCTURE SITE INFECTION. REPORTED AS RELATED TO THE PROCEDURE (DUE TO INSUFFICIENT PUNCTURE SITE PRESSURE), BUT NOT RELATED TO THE STUDY DEVICES. THE PATIENT WAS TREATED WITH PRESSURE TO THE PUNCTURE SITE AND ANTIBIOTICS. THE SUBJECT WAS STARTED THE ADMINISTRATION OF ANTIBIOTICS AND PRESSURE WAS APPLIED FOR THE HEMATOMA, BUT THIS WAS DIFFICULT DUE TO TENDERNESS. THERE WAS A SMALL AMOUNT OF BLEEDING FROM THE PUNCTURE SITE. THEREFORE, AFTER THE PUNCTURE SITE WAS CUT 2CM, THE HEMATOMA WAS REMOVED AND THE PUNCTURE SITE WAS SUTURED AND PRESSURED ON (B)(6) 2014. THE PHYSICIAN CONTINUED PRESSURE, BUT THE BLEEDING CONTINUED TO OOZE. THE PUNCTURE SITE WAS RE-SUTURED AND CLOSED COMPLETELY. AFTER SUTURE REMOVAL, THE PUNCTURE SITE WAS RE-SUTURED AGAIN ON SFA STENOSIS USED THE THS-SX-C AND SPD2-060-190 2014. THERE WAS NO EFFUSION TO THE GAUZE. ON (B)(6) 2014 ALL SUTURES WERE REMOVED AND THE PATIENT WAS DISCHARGED WITHOUT ISSUE ON (B)(6) 2014. PLEASE REFERENCE MDR 2183870-2014-00207 FOR THE TURBOHAWK USED IN THIS PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498182 SPIDERFX EMBOLIC PROTECTION DEVICE TEMPORARY CAROTID CATHETER FOR EMBOLIC CAPTURE NTE COVIDIEN SPD2-060-190 9852927

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other