BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONFIANZA PRO PTCA GUIDE WIRE

    MDR report key: 2013412 · Received March 10, 2011

    Report

    Report Number
    3003775027-2011-00010
    Event Type
    Malfunction
    Date Received
    March 10, 2011
    Date of Event
    February 15, 2011
    Report Date
    February 15, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K052339
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    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. (B)(4) - PROLAPSED TIP. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. EVALUATION SUMMARY: EVALUATION OF THE RETURNED CONFIANZA NOTED THAT THE GUIDE WIRE WAS SEPARATED AT APPROXIMATELY 10 MM FROM TIP END. A BALLOON CATHETER WAS ALSO RETURNED. THOUGH THE PLASTIC BAGS THAT CONTAINED THE DEVICES AND THE BALLOON CATHETER WERE CAREFULLY CHECKED, THE SEPARATED TIP END THAT WAS REPORTED AS REMOVED FROM THE PATIENT WAS NOT FOUND. STRIATION AND DIMPLES WERE FOUND AT THE GUIDE WIRE SEPARATION SUGGESTING THAT REPEATED BEND FORCE AND PULL FORCE WERE APPLIED DURING USE. THE GUIDE WIRE TIP SEPARATION WAS MOST LIKELY CAUSED DUE TO THE REPEATED BENDING FORCE APPLIED TO THE GUIDE WIRE DURING THE ATTEMPTED REMOVAL FROM THE PROLAPSED CONDITION, AND THE FORCE EXCEEDED THE PRODUCT DESIGN LIMIT, RESULTING IN THE SEPARATION. THE CONFIANZA INSTRUCTIONS FOR USE WARNS: IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE ANY NECESSARY REMEDIAL ACTION. THE LOT HISTORY RECORD WAS REVIEWED AND THERE ARE NO NON-CONFORMITIES FOR THIS LOT. THIS TYPE OF REPORTED EVENT WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    REPORTEDLY DURING THE PROCEDURE TO TREAT A CHRONIC TOTAL OCCLUSION LOCATED IN THE CIRCUMFLEX, THE TIP OF THE CONFIANZA PRO SEPARATED INSIDE A 1.5 X 20 MM NON-ABBOTT BALLOON DILATATION CATHETER. THE GUIDE WIRE WAS ADVANCED TO THE TARGET LESION WITHOUT ISSUE AND THEN THE NON-ABBOTT BALLOON WAS ADVANCED OVER THE CONFIANZA PRO; HOWEVER, THE GUIDE WIRE BECAME PROLAPSED AND WHEN THE PHYSICIAN TRIED PULLING THE GUIDE WIRE BACK, THE TIP OF THE GUIDE WIRE WENT THROUGH THE TIP OF THE BALLOON RESULTING IN THE TIP OF THE GUIDE WIRE SEPARATING. THE SEPARATED TIP WAS REMOVED FROM THE PATIENT INSIDE THE BALLOON DILATATION CATHETER. NO ADDITIONAL MEDICAL INTERVENTION WAS NEEDED TO RETRIEVE THE SEPARATED TIP. THE SEPARATED TIP DID NOT CAUSE ANY PATIENT EFFECTS. THE PATIENT WAS SENT TO SURGERY FOR TREATMENT OF THE CHRONIC TOTAL OCCLUSION. REPORTEDLY, THE PATIENT HAD SEEN ANOTHER CARDIOLOGIST PRIOR TO THIS PROCEDURE, WHO HAD TRIED TO TREAT THE LESION BUT WAS UNABLE TO GET ANYTHING ACROSS. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CONFIANZA PRO PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 090107A321

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR DILATATION CATHETER: APEX 1.5X20