BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SGW STORQ .035 300CM ANGLE STD

    MDR report key: 1645099 · Received March 30, 2010

    Report

    Report Number
    1016427-2010-00036
    Event Type
    Injury
    Date Received
    March 30, 2010
    Date of Event
    March 2, 2010
    Report Date
    March 23, 2010
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K914138
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT IS REPORTED THAT DURING ATTEMPTS TO RECANNULATE A 70-80% OCCLUDED AND CALCIFIED ILIAC ARTERY WITH A CORDIS STORQ WIRE AND A 4 FR ANGIO DYNAMICS DIAGNOSTIC CATHETER, A DISSECTION OCCURRED WITHIN THE VESSEL WALL AND THE PHYSICIAN WAS UNABLE TO PASS THE WIRE TO THE RECONSTITUTING DISTAL VESSEL. ACCESS WAS MADE WITH A WIRE LEFT FROM THE FEMORAL ARTERY INTO THE DISSECTION PLANE AND THEN ONCE AGAIN, AN ATTEMPT WAS MADE FROM THE AORTIC CATHETER TO RECANNULATE THE OCCLUDED ARTERY, WHICH WAS SUCCESSFUL. DURING BALLOON ANGIOPLASTY AND WITH THE FIRST INFLATION OF A POWERFLEX P3 BALLOON CATHETER AT 5 ATMOSPHERES, THE BALLOON RUPTURED. WHEN THE PHYSICIAN TRIED TO PULL THE BALLOON OUT OF THE PATIENT, IT SNAGGED WITHIN THE RUPTURED AREA AND SEPARATED INTO THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE BALLOON WAS SUCCESSFULLY REMOVED. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. INITIALLY IN THE PROCEDURE THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND ALSO CROSSING THE LESION. THE BALLOON WAS ALSO IN AN ACUTE BEND DURING THE PROCEDURE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENTS. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9610978-2010-00065 AND 1016427-2010-00036.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES (2010): CHLORAPREP (CAREFUSION), AMPLATZ (BARD MEDICAL), ISOVUE 370 50:50 RATIO (BRACCO DIAGNOSTICS), INDEFLATOR (MERIT MEDICAL). DIAGNOSTIC CATHETER: 4 FR OMNI FLUSH BY ANGIODYNAMICS. CONCOMITANT MEDICATIONS (2010): HEPARIN. (B) (4). IT IS REPORTED THAT DURING ATTEMPTS TO RECANNULATE A 70-80% OCCLUDED AND CALCIFIED ILIAC ARTERY WITH A CORDIS STORQ WIRE AND A 4 FR ANGIO DYNAMICS DIAGNOSTIC CATHETER, A DISSECTION OCCURRED WITHIN THE VESSEL WALL AND THE PHYSICIAN WAS UNABLE TO PASS THE WIRE TO THE RECONSTITUTING DISTAL VESSEL. ACCESS WAS MADE WITH A WIRE LEFT FROM THE FEMORAL ARTERY INTO THE DISSECTION PLANE AND THEN ONCE AGAIN, AN ATTEMPT WAS MADE FROM THE AORTIC CATHETER TO RECANNULATE THE OCCLUDED ARTERY, WHICH WAS SUCCESSFUL. DURING BALLOON ANGIOPLASTY AND WITH THE FIRST INFLATION OF A POWERFLEX P3 BALLOON CATHETER AT 5 ATMOSPHERES THE BALLOON RUPTURED. WHEN THE PHYSICIAN TRIED TO PULL THE BALLOON OUT OF THE PATIENT, IT SNAGGED WITHIN THE RUPTURED AREA AND SEPARATED INTO THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE BALLOON WAS SUCCESSFULLY REMOVED. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. INITIALLY IN THE PROCEDURE THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND ALSO CROSSING THE LESION. THE BALLOON WAS ALSO IN AN ACUTE BEND DURING THE PROCEDURE. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENTS. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT THAT WERE SUBMITTED UNDER THE FOLLOWING MANUFACTURING NUMBERS 9610978-2010-00065 AND 1016427-2010-00036.

    Description of Event or Problem · 1

    IT IS REPORTED THAT DURING ATTEMPTS TO RECANNULATE A 70-80% OCCLUDED AND CALCIFIED ILIAC ARTERY WITH A CORDIS STORQ WIRE AND A 4 FR DIAGNOSTIC CATHETER BY OMNI FLUSH BY ANGIODYNAMICS, A DISSECTION OCCURRED WITHIN THE VESSEL WALL AND THE PHYSICIAN WAS UNABLE TO PASS THE WIRE TO THE RECONSTITUTING DISTAL VESSEL. ACCESS WAS MADE WITH A WIRE LEFT FROM THE FEMORAL ARTERY INTO THE DISSECTION PLANE AND THEN ONCE AGAIN, AN ATTEMPT WAS MADE FROM THE AORTIC CATHETER TO RECANNULATE THE OCCLUDED ARTERY, WHICH WAS SUCCESSFUL. DURING BALLOON ANGIOPLASTY AND WITH THE FIRST INFLATION OF A POWERFLEX P3 BALLOON CATHETER AT 5 ATM IT RUPTURED. WHEN THE PHYSICIAN TRIED TO PULL THE BALLOON OUT OF THE PATIENT, IT SNAGGED WITHIN THE RUPTURED AREA AND SEPARATED INTO THE PATIENT. THE PATIENT WAS TAKEN TO SURGERY AND THE BALLOON WAS SUCCESSFULLY REMOVED. THE PATIENT WAS IN STABLE CONDITION AFTER THE PROCEDURE. INITIALLY IN THE PROCEDURE THERE WAS DIFFICULTY ADVANCING THE BALLOON CATHETER THROUGH THE VESSEL AND ALSO CROSSING THE LESION. THE BALLOON WAS ALSO IN AN ACUTE BEND DURING THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SGW STORQ .035 300CM ANGLE STD ENDOVASCULAR WIRES & METALS DQX CORDIS CORPORATION NA 70709780

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Life Threatening| R