BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE PROGRESS GUIDE WIRE

    MDR report key: 2974894 · Received February 22, 2013

    Report

    Report Number
    2024168-2013-01062
    Event Type
    Injury
    Date Received
    February 22, 2013
    Date of Event
    January 28, 2013
    Report Date
    January 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K091825
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE COMPLAINT DEVICE WAS RETURNED AND THE REPORTED GUIDE WIRE SEPARATION WAS CONFIRMED VIA RETURNED DEVICE ANALYSIS. HOWEVER, THE REPORTED DIFFICULTY RETRACTING THE WIRE/RESISTANCE COULD NOT BE REPLICATED IN A TESTING ENVIRONMENT AS IT WAS BASED ON OPERATIONAL CIRCUMSTANCES. BASED ON VISUAL ANALYSIS AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGING OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. ADDITIONALLY, A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES WITH THE REPORTED LOT AND A REVIEW OF THE COMPLAINT HISTORY DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A CHRONIC TOTAL OCCLUSION (CTO). THE HT PROGRESS GUIDE WIRE TIP BECAME SEPARATED WHILE ATTEMPTING TO STRAIGHTEN THE J-SHAPED DISTAL TIP DURING USE. THE SEPARATED GUIDE WIRE TIP REMAINED IN THE ARTERY. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL REPORT FILING, ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THE TARGET LESION WAS A CHRONIC TOTAL OCCLUSION (CTO) LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). SLIGHT RESISTANCE WAS NOTED WITH THE CTO LESION PRIOR TO THE GUIDE WIRE SEPARATION. THE PATIENT LEFT THE HOSPITAL THE DAY AFTER THE PROCEDURE. A SCHEDULED PROCEDURE WAS PERFORMED ONE WEEK LATER TO TREAT A LESION AT THE CIRCUMFLEX ARTERY AND THE LEFT ANTERIOR DESCENDING ARTERY (LAD). DURING THE SCHEDULED PROCEDURE, IT WAS CONFIRMED UNDER ANGIOGRAPHY THAT THE SEPARATED GUIDE WIRE TIP REMAINED IN THE SAME POSITION IN THE DISTAL RCA. NO INTERVENTION WAS SCHEDULED TO REMOVE THE GUIDE WIRE TIP, AS IT WAS DECIDED TO LEAVE IT IN PLACE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78538 HI-TORQUE PROGRESS GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2030801

    Patients

    Seq Age Sex Outcome Treatment
    1 Other