BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GOOSENECK SNARE

    MDR report key: 6126960 · Received November 24, 2016

    Report

    Report Number
    2183870-2016-00686
    Event Type
    Injury
    Date Received
    November 24, 2016
    Date of Event
    August 1, 2016
    Report Date
    October 27, 2016
    Manufacturer
    COVIDIEN
    Product Code
    DQY
    PMA / PMN Number
    K970668
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE OF EVENT GIVEN AS DATE OF PUBLICATION OF PAPER. VOLUME 25, SUPPLEMENT 2, AUGUST 2016, PAGES S199¿S200 R. CHETTY, R. ALCOCK, J. SPIRO ABSTRACTS FOR THE 64TH CARDIAC SOCIETY OF AUSTRALIA AND NEW ZEALAND ANNUAL SCIENTIFIC MEETING AND THE INTERNATIONAL SOCIETY FOR HEART RESEARCH AUSTRALASIAN SECTION ANNUAL SCIENTIFIC MEETING, 4 ¿ 7 AUGUST 2016, ADELAIDE, AUSTRALIA COPYRIGHT © 2016 PUBLISHED BY ELSEVIER LTD. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO TREAT A SEVERELY CALCIFIED DISTAL LEFT MAIN CORONARY ARTERY(LMCA) OF A PATIENT WITH LONGSTANDING HAEMODIALYSIS DEPENDENT ESRF. SURGICAL INTERVENTION WAS DECLINED DUE TO EXCESSIVE RISK (EUROSCORE (B)(6)%; STS (B)(6)% MORTALITY, (B)(6)% MORBIDITY/MORTALITY). FOLLOWING INTENSIVE HAEMODIALYSIS FOR VOLUME OPTIMISATION, THE PATIENT CAME FORWARD FOR LMCA PCI. 7FR FEMORAL ACCESS WAS GAINED USING AN ULTRASOUND GUIDED MICRO-PUNCTURE TECHNIQUE. USING A 7FR XB3.5 GUIDING CATHETER, ROTATIONAL ATHERECTOMY (1.75MM BURR) WAS PERFORMED SEQUENTIALLY FROM LMCA TO LAD; THEN LMCA TO CIRCUMFLEX. WHILST BURRING INTO THE ANGULATED OSTIUM OF THE CIRCUMFLEX, THE BURR SHEARED THROUGH THE ROTA-WIRE. FOLLOWING PREDILATATION OF THE OSTIAL CIRCUMFLEX, THE FREE ROTA-WIRE WAS SNARED USING A 2MM GOOSENECK SNARE. THE LMCA BIFURCATION WAS THEN TREATED USING A CONVENTIONAL CULOTTE TECHNIQUE; 4 X 28MM (LMCA-LAD) AND 4 X 32MM (LMCA-CIRCUMFLEX) PROMUS PREMIER DRUG-ELUTING STENTS; WITH FINAL KISSING BALLOON INFLATION USING 3.5MM NC BALLOONS AT 12ATM. UPON RETURN TO THE WARD, THE PATIENT RAPIDLY DETERIORATED SECONDARY TO PERICARDIAL TAMPONADE REQUIRING URGENT PERICARDIOCENTESIS AND HEPARIN REVERSAL. REVIEW OF ANGIOGRAPHY REVEALED EVIDENCE OF A CORONARY PERFORATION WITHIN THE DISTAL CIRCUMFLEX, PRESUMABLY RELATED TO SNARING. THE PATIENT SUBSEQUENTLY RECOVERED WELL AND WAS DISCHARGED ON DAY SEVENTEEN. ROTATIONAL ATHERECTOMY WITHIN HEAVILY CALCIFIED, ANGULATED LESIONS MAY BE EXTREMELY CHALLENGING. SNARE RETRIEVAL OF A FREE ROTA WIRE MAY BE POSSIBLE IN THE UNLIKELY EVENT OF WIRE SHEAR, HOWEVER THIS IS NOT WITHOUT SIGNIFICANT RISK OF FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777703 GOOSENECK SNARE CATHETER, PERCUTANEOUS DQY COVIDIEN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention