BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD MICRO INTRODUCER KIT

    MDR report key: 2739075 · Received May 11, 2012

    Report

    Report Number
    1319211-2012-00049
    Event Type
    Injury
    Date Received
    May 11, 2012
    Date of Event
    April 9, 2012
    Report Date
    April 13, 2012
    Manufacturer
    ANGIODYNAMICS
    Product Code
    DYB
    PMA / PMN Number
    K032069
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE LOT HISTORY RECORDS WAS PERFORMED FOR THE REPORTED PACKAGING AND COMPONENT LOTS FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY, AND PERFORMANCE SPECS. THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS BEEN RETURNED TO THE MFR FOR EVAL. AN INVESTIGATION INTO THE ROOT CAUSE FOR INCIDENT IS CURRENTLY IN PROGRESS. ONCE THE DEVICE IS RECEIVED AND EVALUATED, THE RESULTS OF THE INVESTIGATION WILL BE SENT VIA A F/U MEDWATCH. ADD'L INFO FROM U/F REPORT # (B)(4). BRAND NAME: ANGIODYNAMICS, INC., COMMON DEVICE NAME: 5F STANDARD MICRO-INTRODUCER KIT. (B)(6).

    Description of Event or Problem · 1

    A (B)(6) MALE PRESENTED FOR DECLOTTING PROCEDURE OF A LEFT ARTERIOVENOUS GRAFT. DURING THE PROCEDURE THE 0.018" X 45CM MICROACCESS WIRE SHEARED OFF DURING ACCESS TOWARDS THE ARTERIAL SIDE OF THE AV GRAFT. THE FOREIGN BODY (PIECE OF THE WIRE) WAS LOCATED UNDER X-RAY AND SUCCESSFULLY RETRIEVED WITH A SNARE WITHOUT DIFFICULTY. IT WAS REPORTED THAT THE PT SUFFERED NO HARM OR INJURY DUE TO THIS EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT FURTHER COMPLICATIONS. ON 04/16/2012, THE FIRM RECEIVED USER MEDWATCH (B)(4). ADD'L INFO FROM U/F REPORT: A (B)(6) MALE HAVING DECLOTTING OF LEFT AV GRAFT; DURING PROCEDURE MICROPUNCTURE GUIDEWIRE SHEARED OFF DURING ACCESS TOWARDS ARTERIAL SIDE OF AV GRAFT. FOREIGN BODY (PIECE OF WIRE) FOUND UNDER X-RAY AND RETRIEVED WITH A SNARE WITHOUT DIFFICULTY. PT SUFFERED NO HARM. PROCEDURE WAS COMPLETED. BROKEN GUIDEWIRE AND INTRODUCER AVAILABLE FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STANDARD MICRO INTRODUCER KIT MICRO INTRODUCER KIT DYB ANGIODYNAMICS 565110

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention