BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI SOFT PTCA GUIDE WIRE

    MDR report key: 7131477 · Received December 19, 2017

    Report

    Report Number
    3003775027-2017-00243
    Event Type
    Injury
    Date Received
    December 19, 2017
    Date of Event
    October 25, 2017
    Report Date
    January 3, 2018
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INTERNAL FILE NUMBER - (B)(4): DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. (B)(4). ATTACHMENT: USER FACILITY MEDWATCH REPORT# (B)(4).

    Additional Manufacturer Narrative · 1

    INTERNAL FILE NUMBER - (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: THE DEVICE WAS NOT RETURNED FOR ANALYSIS. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT AND NO OTHER SIMILAR PRODUCT EXPERIENCE REPORT WAS RECEIVED. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CIRCUMSTANCES OF THE PROCEDURE. ALTHOUGH THE DEVICE INVESTIGATION COULD NOT BE CONDUCTED, THERE WAS NO INDICATION OF PRODUCT DEFICIENCY AS ALL THE SHIPPED PRODUCTS WERE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA.

    Description of Event or Problem · 1

    DURING RIGHT CORONARY ARTERY INTERVENTION THE GUIDEWIRE GOT STUCK IN THE RIGHT CORONARY ARTERY (RCA) AND MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE IT. THE TIP OF THE GUIDEWIRE SHEARED OFF IN THE ABDOMINAL AORTA. ATTEMPTS AT SNARING THE WIRE WERE UNSUCCESSFUL. PATIENT WAS LATER TRANSFERRED TO ANOTHER FACILITY FOR EVALUATION OF THE RETAINED CORONARY WIRE. AT THE RECEIVING FACILITY THE PATIENT WAS EVALUATED BY CARDIOTHORACIC, AND VASCULAR SURGERY. PATIENT WAS DEEMED TOO HIGH RISK AND NOT AN OPERATIVE CANDIDATE DUE TO COMORBIDITIES. INTERVENTIONAL CARDIOLOGIST OFFERED A VERY HIGH-RISK CATHETER (SNARE) ATTEMPT AT WIRE REMOVAL WHICH WAS DECLINED BY THE PATIENT AND FAMILY. THE PATIENT REQUESTED TRANSFER TO (B)(6) HOSPITAL ((B)(6)). PATIENT RETURNED TO CMH AND DISCHARGED HOME ON (B)(6) 2017 IN STABLE CONDITION. ADDITIONAL INFORMATION RECEIVED NOTED THAT THE TARGET LESION WAS HEAVILY CALCIFIED AND TORTUOUS IN THE PROXIMAL RCA. THE GUIDE WIRE GOT STUCK WITH CALCIUM AND POSSIBLY THE PROXIMAL END OF THE STENT. THEN A BALLOON CATHETER WAS ADVANCED IN AN ATTEMPT TO REMOVE THE GUIDE WIRE AND IT STILL WOULD NOT COME OUT. THE BALLOON WAS REMOVED AND WHEN THE WIRE WAS PULLED ON THE TIP SEPARATED. THERE WAS NO EXCESSIVE PULLING AT ANY TIME DURING ANY OF THE ATTEMPTS TO REMOVE THE GUIDE WIRE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    909981 ASAHI SOFT PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 170411A051

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R