BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CRICKET MICRO-INFUSION CATHETER

    MDR report key: 1887260 · Received October 29, 2010

    Report

    Report Number
    3004142795-2010-00001
    Event Type
    Injury
    Date Received
    October 29, 2010
    Date of Event
    December 30, 2009
    Report Date
    December 30, 2009
    Manufacturer
    MERCATOR MEDSYSTEMS, INC.
    Product Code
    KRA
    PMA / PMN Number
    K062752
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A PATIENT WAS ENROLLED IN THE ATHERSYS MULTISTEM TRIAL 4 DAYS AFTER A 3.0 MM MEDTRONIC ENDEAVOR STENT HAD BEEN PLACED IN THE PROXIMAL LAD. ON INITIAL ANGIOGRAPHY, THE STENT APPEARED FULLY APPOSED TO THE ARTERY, BUT WAS SEEN TO BE UNDER-EXPANDED (<2.35 MM) AT ITS PROXIMAL AND DISTAL ENDS BY IVUS (ICROSS, BOSTON SCIENTIFIC). THE CRICKET CATHETER WAS INSERTED INTO THE CORONARY ARTERY AND PASSED INTO THE STENT, BUT WOULD NOT ADVANCE BEYOND THE DISTAL END OF THE STENT. MULTIPLE ATTEMPTS WERE MADE TO CROSS THE STENT BY MANIPULATING THE CRICKET CATHETER, BUT ALL ATTEMPTS WERE UNSUCCESSFUL. THE CRICKET CATHETER WAS THEN WITHDRAWN FROM THE ARTERY WITHOUT PERCEPTIBLE RESISTANCE. THE IVUS CATHETER WAS THEN PASSED, WITHOUT DIFFICULTY, THROUGH THE STENT AND IMAGING SHOWED THAT THE STENT HAD SHORTENED AND NARROWED. UPON WITHDRAWAL, THE IVUS CATHETER BECAME CAUGHT ON THE STENT AND REQUIRED FORCIBLE REMOVAL FROM THE ARTERY, CAUSING THE STENT TO BE DISPLACED FROM ITS ORIGINAL POSITION. A BALLOON WAS USED TO RE-EXPAND THE STENT AGAINST THE VESSEL WALL. THE ORIGINAL CRICKET CATHETER APPEARED TO HAVE A LEAK, SO A SECOND CRICKET CATHETER WAS PREPARED AND ADVANCED BEYOND THE STENT WITHOUT DIFFICULTY. THE SECOND CRICKET CATHETER WAS DEPLOYED AND INFUSION OF THE TEST ARTICLE WAS SUCCESSFUL. THE CRICKET CATHETER WAS REMOVED AND AN ADDITIONAL ENDEAVOR STENT WAS PLACED OVER THE LOCATION WHERE THE PRIOR ENDEAVOR STENT HAD BEEN PULLED BACK. THE NEED FOR INTERVENTION WITH THE PLACEMENT OF THE SECOND ENDEAVOR STENT WAS DUE TO THE FOLLOWING FACTORS: THE ATTEMPT TO PASS THE CRICKET CATHETER THROUGH THE ORIGINAL, UNDER-EXPANDED STENT WHICH CAUSED THE CRICKET CATHETER TO CATCH ON THE STENT TINES; AND THE IVUS CATHETER CATCHING ON THE UNDER-EXPANDED STENT TINES UPON REMOVAL OF THE IVUS CATHETER. THESE FACTORS CAUSED FURTHER NARROWING AND ULTIMATELY DISPLACEMENT OF THE STENT WHICH NECESSITATED PLACEMENT OF A SECOND STENT. THE LEAK NOTED IN THE CRICKET CATHETER WAS NOT DIRECTLY RELATED TO THE NEED FOR INTERVENTION. THE DAY AFTER THE PROCEDURE, THE PATIENT WAS RELEASED FROM THE HOSPITAL, IN KEEPING WITH THE PROTOCOL AND WITHOUT COMPLICATION(S). HOSPITAL LENGTH-OF-STAY WAS UNAFFECTED BY THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRICKET MICRO-INFUSION CATHETER CONTINUOUS FLUSH INFUSION CATHETER KRA MERCATOR MEDSYSTEMS, INC. MDL09-2530-145 00266

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention MEDTRONIC ENDEAVOR DRUG ELUTING STENT| BOSTON SCIENTIFIC ICROSS IVUS CATHETER