BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 5398799 · Received January 29, 2016

    Report

    Report Number
    3003775027-2016-00019
    Event Type
    Malfunction
    Date Received
    January 29, 2016
    Date of Event
    January 7, 2016
    Report Date
    October 11, 2016
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UNIQUE DEVICE IDENTIFIER (UDI): THE UDI IS UNKNOWN BECAUSE THE PART NUMBER AND LOT NUMBER WAS NOT PROVIDED. THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: WITH THE PROVIDED INFORMATION, THE CAUSE AND THE CIRCUMSTANCE OF THE RESISTANCE WITH THE REPORTED BALLOON CATHETER COULD NOT BE IDENTIFIED. THOUGH LOT HISTORY REVIEW COULD NOT BE MADE BECAUSE OF NO LOT INFORMATION PROVIDED, SINCE ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING THE PRODUCT SPECIFICATIONS AND RELEASE CRITERIA, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. WARNING SECTION OF INSTRUCTIONS FOR USE DESCRIBES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE 2.5X15MM TREK REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH MFR NUMBER. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS WAS AN UN-SPECIFIED PROCEDURE. DURING ADVANCEMENT AND REMOVAL OF THE 2.5 X 15 MM TREK BALLOON CATHETER, RESISTANCE WAS NOTED WITH THE PROWATER GUIDE WIRE. MULTIPLE HEPARINIZED SALINE FLUSHES WERE PERFORMED, BUT THE RESISTANCE CONTINUED. THE PROCEDURE WAS CONTINUED WITH THE SAME DEVICES AND THERE WAS A GOOD PATIENT OUTCOME. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58383 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1