BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDTRONIC

    MDR report key: 2281 · Received January 12, 1993

    Report

    Report Number
    2281
    Event Type
    Malfunction
    Date Received
    January 12, 1993
    Date of Event
    December 1, 1992
    Report Date
    December 9, 1992
    Manufacturer
    MEDTRONIC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    PATIENT IS A 72 YEAR OLD MALE IN CATH LAB FOR PTCA. PATIENT HAD HISTORY OF CAD-S/P PTCA 9/90, PULMONARY EMBOLISM 9/90 AND DVT 4/91. GREENFIELD FILTER IN PLACE AND PATIENT TAKES COUMADIN UP TO 6 DAYS PREPROCEDURE. ON 12/1/92 PATIENT WAS UNDERGOING CARDIAC CATH WHEN AT 16:32 THERE WAS A FRACTURE OF RCA GUIDING (MEDTRONIC - 8F JR 3.5 . REMAINING GUIDEWIRE EXTENDING FROM RIGHTILIAC TO AORTIC ARCH. ATTEMPT THEN MADE TO RETREIVE GUIDE WITH A SNARE. A .014 KTF WIRE WAS PLACED AND THREADED UP NEAR GUIDES. A 2.5 MM (REACH) BALLOON WAS USED TO ATTEMPT TO PULL GUIDE OUT, THEN A STONE RETIEVAL SETUP WAS USED TO RETRIEVE GUIDES. BIOTOME WAS ALSO USED WHEN REPLACING 8FR SHEATH ON RIGHT ARTERIAL ACCESS WAS LOST. PATIENT HAD AN IABP IN PLACE, LEFT FEMORAL ARTERY AND THIS WAS REMOVED OVER THE WIRE, THEN SNARE PLACED UP LEFT GROIN AND DISTAL END OF GUIDE WAS PULLED OUT THROUGH THE 10 FR SHEATH IN THE LEFT GROIN. PATIENT DEVELOPED A HEMATOMA TO THE RIGHT FEMORAL SITE DUE TO REMOVAL OF SHEATH WHILE HE WAS ANTICOAGULATED. THIS WAS CONTROLLED BY PROLONGED PRESSURE ON THE FEMORAL ARTERY. PATIENT HAD APPROXIMATE THREE (3) HOURS OF RETRIEVAL TIME OF FRAGMENTED GUIDING CATH IN CATH LAB. FURTHER EFFORTS AT DILATING THE RIGHT CORONARY WERE NOT MADE. THE VESSEL WAS NEVER CONNECTED WITH THE GUIDE. PATIENT WAS DISCHARGED TO HOME ON 12/3/92 FULLY AMBULATORYDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, NONE OR UNKNOWN, OTHER. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: DEVICE PERMANENTLY REMOVED FROM SERVICE, DEVICE RETURNED TO MANUFACTURER/DEALER/DISTRIBUTOR, OTHER. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC MEDTRONIC INTERVENTIONAL VASCULAR GUIDING CATHETER DQX MEDTRONIC 8F JR 3.5 11326

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Other