BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN CARDIOLOGY GUIDING CATHETER

    MDR report key: 3987044 · Received August 7, 2014

    Report

    Report Number
    9616099-2014-00517
    Event Type
    Injury
    Date Received
    August 7, 2014
    Date of Event
    June 20, 2013
    Report Date
    July 17, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K971572
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DESCRIPTION CONTINUED: FIRST, LMCA WAS STENTED WITH AN EVAROLIMUS ELUTING STENT (XIENCE V, ABBOTT VASCULAR) AND FLOW RE ESTABLISHED INTO LMCA & LAD SYSTEM. STILL, THERE WAS NO FLOW IN LCX. SO, BALLOON ANGIOPLASTY WITH EMPIRA NC BALLOON WAS DONE IN OSTIO-PROXIMAL LCX AND FOLLOWED BY KISSING BALLOON ANGIOPLASTY WAS DONE IN BOTH LAD & LCX OSTIUM WITH 3 X10MM& 2.75 X 10MM EMPIRA NC BALLOON (CORDIS) RESPECTIVELY. FINALLY, TIMI (THROMBOLYSIS IN MYOCARDIAL INFARCTION) III FLOW WAS REESTABLISHED IN LEFT CORONARY SYSTEM AND PATIENT ALSO HAD NORMAL CARDIAC ACTIVITY. HE WAS GIVEN INJECTION OF EPTIFIBATIDE INFUSION FOR 24 H. TILL 6 MONTHS OF FOLLOW UP AFTER CORONARY INTERVENTION, PATIENT WAS REMAINED ASYMPTOMATIC. THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW. THE CITATION IS AS FOLLOWS: BADNUR, S. (2013 JUNE 20).INADVERTENT LEFT AORTO-CORONARY DISSECTION FOLLOWING PERCUTANEOUS CORONARY INTERVENTION TREATED SUCCESSFULLY BY BAIL-OUT LEFT MAIN CORONARY ARTERY STENTING. JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH, 4, 84-86. THIS IS THE INITIAL AND FINAL REPORT FOR THIS COMPLAINT DEVICE. COMPLAINT CONCLUSION: AS NOTED IN THE PUBLICATION BY BADNUR ET AL INADVERTENT LEFT AORTO-CORONARY DISSECTION FOLLOWING PERCUTANEOUS CORONARY INTERVENTION TREATED SUCCESSFULLY BY BAIL-OUT LEFT MAIN CORONARY ARTERY STENTING , JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH 4 (2013) 84-86; A 42-YEAR-OLD PATIENT PRESENTED WITH EFFORT ANGINA OF CANADIAN CARDIOVASCULAR SOCIETY (CCS) GRADE II FOR LAST 2-3 MONTHS. HE WAS A SMOKER AND KNOWN HYPERTENSIVE. GENERAL AND SYSTEMIC EXAMINATION WAS FOUND TO BE WITHIN NORMAL LIMIT EXCEPT BLOOD PRESSURE OF 150/90 MM OF HG. HIS BLOOD INVESTIGATION REVEALED ONLY PRESENCE OF DYSLIPIDEMIA (LOW DENSITY LIPOPROTEIN E 165 MG/DL & TRIGLYCERIDE 290 MG/DL). ELECTROCARDIOGRAM DIDN¿T SHOW ANY SIGNIFICANT ABNORMALITY THOUGH HE HAD A POSITIVE TREADMILL TEST AT 8 METS. HE WAS ADMITTED FOR CORONARY ANGIOGRAM WHICH REVEALED SIGNIFICANT LESION IN PROXIMAL LAD AND DISTAL LCX. AS HE HAD SIGNIFICANT EFFORT ANGINA, SO PERCUTANEOUS CORONARY INTERVENTION (PCI) & STENTING OF LAD AND PCI WITH BALLOON ANGIOPLASTY OF DISTAL LCX WAS PLANNED. FIRST, WE HAD DONE STENTING OF LAD WITH AN EVAROLIMUS ELUTING STENT (XIENCE V,ABBOTT VASCULAR) AND FOLLOWED BY BALLOON ANGIOPLASTY OF LCX WAS DONE WITH AN EMPIRA NC BALLOON (CORDIS) OF 2.5 X 10 MM DIAMETER. THE GUIDING CATHETER USED IN THIS CASE WAS JUDKIN¿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

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION BY BADNUR ET AL INADVERTENT LEFT AORTO-CORONARY DISSECTION FOLLOWING PERCUTANEOUS CORONARY INTERVENTION TREATED SUCCESSFULLY BY BAIL-OUT LEFT MAIN CORONARY ARTERY STENTING , JOURNAL OF CARDIOVASCULAR DISEASE RESEARCH 4 (2013) 84-86; A 42-YEAR-OLD PATIENT PRESENTED WITH EFFORT ANGINA OF CANADIAN CARDIOVASCULAR SOCIETY (CCS) GRADE II FOR LAST 2-3 MONTHS. HE WAS A SMOKER AND KNOWN HYPERTENSIVE. GENERAL AND SYSTEMIC EXAMINATION WAS FOUND TO BE WITHIN NORMAL LIMIT EXCEPT BLOOD PRESSURE OF 150/90 MM OF HG. HIS BLOOD INVESTIGATION REVEALED ONLY PRESENCE OF DYSLIPIDEMIA (LOW DENSITY LIPOPROTEIN E 165 MG/DL & TRIGLYCERIDE 290 MG/DL). ELECTROCARDIOGRAM DIDN¿T SHOW ANY SIGNIFICANT ABNORMALITY THOUGH HE HAD A POSITIVE TREADMILL TEST AT 8 METS. HE WAS ADMITTED FOR CORONARY ANGIOGRAM WHICH REVEALED SIGNIFICANT LESION IN PROXIMAL LAD AND DISTAL LCX. AS HE HAD SIGNIFICANT EFFORT ANGINA, SO PERCUTANEOUS CORONARY INTERVENTION (PCI) & STENTING OF LAD AND PCI WITH BALLOON ANGIOPLASTY OF DISTAL LCX WAS PLANNED. FIRST, WE HAD DONE STENTING OF LAD WITH AN EVAROLIMUS ELUTING STENT (XIENCE V,ABBOTT VASCULAR) AND FOLLOWED BY BALLOON ANGIOPLASTY OF LCX WAS DONE WITH AN EMPIRA NC BALLOON (CORDIS) OF 2.5 X 10 MM DIAMETER. THE GUIDING CATHETER USED IN THIS CASE WAS JUDKIN¿S LEFT GUIDING CATHETER (JL 3.5, 7 FR, CORDIS). AFTER DOING ANGIOPLASTY OF LCX, THE GUIDING CATHETER, GUIDE WIRE & ANGIOPLASTY BALLOON WAS REMOVED SUDDENLY & INADVERTENTLY WHICH CAUSED GUIDING CATHETER INDUCED DISSECTION OF LEFT AORTO-CORONARY OSTIUM, LCX OSTIUM WITH NO FLOW IN LEFT CORONARY SYSTEM. THE PATIENT WENT INTO CARDIAC ARREST IMMEDIATELY AFTER THE UNTOWARD INCIDENT HAPPENED. HE WAS RESUSCITATED IMMEDIATELY AND CATHETER BASED INTERVENTION PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463991 UNKNOWN CARDIOLOGY GUIDING CATHETER CARDIOLOGY GUIDING CATHETER DQY CORDIS DE MEXICO NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Hospitalization| L| R| S EMPIRA NC BALLOON 2.5 X 10 MM