BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

    MDR report key: 4190174 · Received October 21, 2014

    Report

    Report Number
    2024168-2014-06857
    Event Type
    Injury
    Date Received
    October 21, 2014
    Date of Event
    September 15, 2014
    Report Date
    September 26, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    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. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A QUERY/REVIEW OF THE ELECTRONIC COMPLAINT DATABASE REVEALED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED. A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE ON (B)(6) 2014 WAS ANGIOPLASTY AT THE RIGHT RADIAL ARTERY IN A PATIENT FOR HAEMODIALYSIS IN THE DISTAL PORTION OF THE FOREARM. AFTER ABOUT 2 HOURS, THE PATIENT UNDERWENT AN ECHOGRAPH EXAM DUE TO A SUDDEN HEMATOMA AT THE THIRD MIDDLE DISTAL OF THE RIGHT ARM. THE INVESTIGATION SHOWED PSEUDO-ANEURYSM AT THE LEVEL OF THE PUNCTURE SITE. THROMBIN WAS INJECTED VIA PERCUTANEOUS ACCESS INTO THE PSEUDOANEURYSM CAVITY TO FILL THE PSEUDOANEURYSM. THEN AN ANGIOPLASTY IS PERFORMED WITH BALLOON 3 MM X 80 MM WITH GOOD CLINICAL RESULT. THERE WAS NO RESISTANCE REPORTED DURING ADVANCEMENT OR RETRACTION OF THE GUIDE WIRE IN THE ANATOMY. THE DAY AFTER, DURING ECHOGRAPH CONTROL, THE PRESENCE OF AN EXTRANEOUS BODY IN THE RADIAL ARTERY LUMEN AND AFFERENT VEIN WAS OBSERVED. AN X-RAY WAS PERFORMED AND CONFIRMED THE PRESENCE OF THE BODY. THE EXTRANEOUS BODY WAS DETERMINED TO BE A PORTION OF THE GUIDE WIRE (LENGTH: ABOUT 25 CM) USED THE DAY BEFORE. WITH A LACE CATHETER AND ACCESS FROM THE AFFERENT VEIN THE GUIDE WIRE WAS TAKEN OUT. THE PATIENT IS REPORTED TO BE FINE WITH A NORMAL FUNCTIONING ARTERIOVENOUS FISTULA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    668405 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDE WIRE DQX AV-TEMECULA-CT 4043071

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R