BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANGIODYNAMICS INC. MICRO ACCESS KITS

    MDR report key: 6756713 · Received August 1, 2017

    Report

    Report Number
    1319211-2017-00077
    Event Type
    Injury
    Date Received
    August 1, 2017
    Date of Event
    June 22, 2017
    Report Date
    September 20, 2017
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DQX
    UDI-DI
    H787065970145
    PMA / PMN Number
    K051655
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED, ANGIODYNAMICS IS UNABLE TO PERFORM A DEVICE EVALUATION. THE CUSTOMER'S REPORTED COMPLAINT DESCRIPTION OF THE GUIDEWIRE UNRAVELING COULD NOT BE CONFIRMED BECAUSE NO SAMPLE WAS RETURNED. A POSSIBLE ROOT CAUSE FOR THE REPORTED COMPLAINT IS THAT THE END USER PULLED THE GUIDEWIRE BACK THROUGH THEN NEEDLE. THE WELDED TIP OF THE GUIDEWIRE COULD BECOME CAUGHT ON THE BEVELED EDGE OF THE NEEDLE CAUSING THE WIRE TO BECOME UNCOILED AND BREAK, HOWEVER, THIS CANNOT BE DEFINITIVELY DETERMINED AT THIS TIME AS THE REPORTED DEFECTIVE DEVICE WAS NOT RETURNED. A LOT HISTORY RECORDS SEARCH REVEALED NO QUALITY RELATED ISSUES OR MANUFACTURING DEFICIENCIES AT THE TIME OF MANUFACTURE. THE INSTRUCTIONS FOR USE, WHICH IS SUPPLIED TO THE END USER WITH THIS CATALOG NUMBER INSTRUCTS THE USER TO GAIN PERCUTANEOUS ACCESS WITH THE 21 GA. ENTRY NEEDLE. ADVANCE THE 0.018" GUIDEWIRE THROUGH THE 21 GA. NEEDLE. WITHDRAW THE ENTRY NEEDLE WHILE LEAVING THE 0.018" GUIDEWIRE IN PLACE. ADVANCE THE SHEATH/DILATOR SET OVER THE 0.018" GUIDEWIRE. REMOVE THE 0.018" GUIDEWIRE". A REVIEW OF THE ANGIODYNAMICS COMPLAINT SYSTEM NOTED NO ADVERSE TRENDS FOR THIS COMPLAINT TYPE AND PRODUCT FAMILY. THIS TYPE OF COMPLAINT WILL CONTINUE TO BE MONITORED FOR TRENDS. COMPLAINT REFERENCE (B)(4).

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE DISPOSABLE DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. AN INVESTIGATION INTO THE ROOT CAUSE OF THIS INCIDENT IS CURRENTLY IN PROGRESS. THE RESULTS OF THE DEVICE EVALUATION WILL BE SENT VIA A FOLLOW UP MEDWATCH. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED TO ANGIODYNAMICS ON JULY 06, 2017 VIA USER MEDWATCH (B)(4): PATIENT TO CARDIAC CATH LAB FOR CARDIAC ELECTROPHYSIOLOGIC STUDY/CATHETER ABLATION ON (B)(6) 2017. MICRO-PUNCTURE WIRE BROKE AND LEFT A TINY PIECE IN THE LEFT GROIN SUBCUTANEOUS TISSUE AREA WHILE TRYING TO ENTER THE LEFT FEMORAL VEIN IN THE BEGINNING OF THE CASE. PEDS ECHO DONE ON DAY OF PROCEDURE; NO EVIDENCE OF CLOT OR THROMBUS FORMATION IN THE LEFT ATRIAL APPENDAGE. ON THE DAY AFTER THE PROCEDURE, VENOUS DOPPLER REPORT - NO EVIDENCE OF LEFT LOWER EXTREMITY ACUTE DEEP VENOUS THROMBOSIS. XRAY OF PELVIS DONE (B)(6) 2017 - SUGGESTION OF VERY THIN FOREIGN BODY ALONG THE MEDIAL ASPECT OF THE FEMORAL HEAD LIKELY REPRESENTING SMALL RETAINED WIRE. PHYSICIAN DETERMINED NOT TO REMOVE THE FRAGMENT. PATIENT DISCHARGED HOME (B)(6) 2017. IT WAS REPORTED THE DEFECTIVE DISPOSABLE DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    536987 ANGIODYNAMICS INC. MICRO ACCESS KITS MICRO ACCESS AND MICRO INTRODUCERS DQX ANGIODYNAMICS H787065970145

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR Required Intervention