BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM

    MDR report key: 136961 · Received December 5, 1997

    Report

    Report Number
    2247023-1997-00357
    Event Type
    Malfunction
    Date Received
    December 5, 1997
    Date of Event
    May 12, 1997
    Report Date
    October 23, 1997
    Manufacturer
    NEW JERSEY PLANT
    Product Code
    MAF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO INITIALLY RECEIVED STATED THAT THE STENT EMBOLIZED AND NO ATTEMPTS WERE MADE TO RETRIEVE THE STENT; HOWEVER, A STENT WAS RETURNED WITH THE DELIVERY SYSTEM. ALSO, THE RETURNED DEVICE WAS OBSERVED TO BE FREE AND CLEAN OF ANY DRIED BLOOD. THE INITIALLY REPORTED LOT NUMBER WAS OBSERVED TO BE DIFFERENT THEN THE LOT NUMBER ON THE RETURNED PRODUCT (122783). CORDIS CONTACTED THE AFFILIATE TO CONFIRM THAT THE RETURNED PRODUCT WAS THE CORRECT PRODUCT ASSOCIATED WITH THIS COMPLAINT. THE AFFILIATE STATED THAT THE CORRECT PRODUCT HAD BEEN RETURNED. THE CO'S PRODUCT EVALUATION FOUND THAT ALTHOUGH NO CONCLUSION COULD BE DETERMINED AS TO THE CAUSE OF THE GUIDING CATHETER AND THE SDS NOT ADVANCING BEYOND THE MID-LAD, THE CONDITION OF THE STENT WAS ATTRIBUTED TO USER HANDLING. THE DRIED CONTRAST MEDIA IN THE TUOHY-BORST AND IN THE SHEATH LUMEN OBSERVED DURING THE PRODUCT EVALUATION INDICATES THAT THE OPERATOR ATTEMPTED TO INFLATE THE BALLOON USING THE SHEATH PORT RATHER THEN THE BALLOON PORT. IN AN ATTEMPT TO CLARIFY INFO RECEIVED FROM THE AFFILIATE RELATIVE TO THE PRODUCT WHICH WAS RETURNED FOR EVALUATION, THIS FOLLOW-UP REPORT IS BEING SUBMITTED SEVERAL DAYS BEYOND ITS DUE DATE.

    Description of Event or Problem · 1

    AN ATTEMPT TO ADVANCE A CORONARY STENT WITH DELIVERY SYSTEM (SDS) TO THE TARGET LESION SITE IN THE PT'S LEFT ANTERIOR DESCENDING ARTERY (LAD) WAS UNSUCCESSFUL BECAUSE THE GUIDING CATHETER AND SDS WOULD NOT ADVANCE BEYOND THE MID-LAD. IN RESPONSE, AN ATTEMPT TO WITHDRAW THE GUIDE CATHETER ALONG WITH THE SDS WAS MADE. UPON WITHDRAWAL, THE STENT BECAME DISLODGED FROM THE BALLOON CATHETER AND EMBOLIZED IN THE PT'S FEMORAL ARTERY. THERE WERE NO ATTEMPTS MADE TO RETRIEVE THE STENT. THERE WERE NO ADD'L COMPLICATION REPORTED RELATIVE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ SCHATZ BALLOON EXPANDABLE STENT WITH DELIVERY SYSTEM Implant CORONARY STENT WITH DELIVERY SYSTEM MAF NEW JERSEY PLANT NA 108146

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN