BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 5189679 · Received October 29, 2015

    Report

    Report Number
    3003775027-2015-00133
    Event Type
    Injury
    Date Received
    October 29, 2015
    Date of Event
    October 9, 2015
    Report Date
    October 13, 2016
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K070945
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. (B)(4), REGISTRATION NUMBER: 3003780911. (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD. BASED ON THE OUTCOMES OF THE INVESTIGATION, INCLUDING SCANNING ELECTRON MICROSCOPY, IT IS INFERRED THAT THE TIP OF THE GUIDE WIRE MIGHT BE TRAPPED BY UNIDENTIFIED CAUSE IN THE VESSEL, WHERE EXCESSIVE ROTATIONAL MANIPULATION WAS MADE TO THE GUIDEWIRE, RESULTING THE BREAKAGE OF THE CORE WIRE WITH THE FORCE EXCEEDING THE PRODUCT DESIGN LIMIT. ALONG WITH REMOVAL OF THE GUIDEWIRE SUPPOSEDLY, THE COIL WAS ELONGATED AND ENTIRELY PULLED APART FROM THE GUIDEWIRE. ALL PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA. THE INFORMATION FOR USE STATES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDEWIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDEWIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDEWIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDEWIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. WHEN TORQUING THE GUIDEWIRE INSIDE THE BLOOD VESSEL, DO NO TORQUE CONTINUOUSLY IN THE SAME DIRECTION. THIS MAY CAUSE THE GUIDEWIRE TO BECOME DAMAGED OR BREAK APART, CAUSING INJURY TO THE BLOOD VESSEL OR LEAVING FRAGMENTS INSIDE THE VESSEL. WHEN TORQUING THE GUIDEWIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (720 DEGREE) IN THE SAME DIRECTION. SEPARATION OR BREAKAGE OF GUIDEWIRE AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. A REVIEW OF THE LOT HISTORY REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS TO INSERT A PERMANENT PACEMAKER IN THE CORONARY SINUS. A GRANDSLAM GUIDE WIRE WAS ADVANCED WITH NO RESISTANCE NOTED, BUT AS SOON AS THE GUIDE WIRE WAS PLACED IT SPONTANEOUSLY SEPARATED. THE SEPARATED PORTION WAS NOT RETRIEVED, SINCE, IT WAS IN THE CORONARY SINUS, AND THE PHYSICIAN AFFIRMED IT DID NOT NEED TO BE RETRIEVED. THE SEPARATED GUIDE WIRE PORTION IS LOCATED IN THE SMALLEST PART OF THE CORONARY SINUS. THE PATIENT IS DOING FINE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    720515 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 131015A031

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Other