BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPORT AP ASPIRATION CATHETER

    MDR report key: 3863819 · Received June 10, 2014

    Report

    Report Number
    1220452-2014-00030
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 8, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DXE
    PMA / PMN Number
    K081573
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION, RESULTS: (INCONCLUSIVE, EVALUATION IN PROGRESS). CONCLUSION: CONCLUSION NOT YET AVAILABLE (EVALUATION IN PROGRESS). (B)(4).

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    RESULTS: RELATED TO OPERATIONAL CONTEXT. (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION: IT IS REPORTED THAT THE DEVICE WAS PREPPED AS PER THE IFU. RESISTANCE WAS NOTED WHEN ADVANCING AND RETRACTING THE DEVICE. IT IS REPORTED THAT SOMETHING SPLIT. THE DEVICE DID NOT DETACH INTO TWO OR MORE PIECES AND NO DEVICE FRAGMENTS REMAINED IN THE PATIENT. EVALUATION SUMMARY: RECEIVED FOR EVALUATION WAS ONE COILED UP EXPORT ASPIRATION CATHETER WITH THE SUPPLIED EXTENSION LINE AND ORIGINAL POUCH WITH MATCHING LOT NUMBER. THE EXPORT EXHIBITED DAMAGE TO THE PROXIMAL EXIT PORT OF THE WIRE LUMEN. AN IN HOUSE 0.014¿ WIRE WAS INSERTED UP TO THE DAMAGED SECTION, THE WIRE DID NOT EXIT THE LUMEN DUE TO THE DAMAGE NOTED. THE EXTENSION LINE EXHIBITED CRUSH MARKS NEAR THE HUB AND THE CONNECTING LUER, MOST LIKELY THIS MARK WAS DONE WITH SOME SORT OF CLAMPING DEVICE. AN IN HOUSE 0.038¿ GUIDE WIRE WAS INSERTED INTO THE LUMEN OF THE RETURNED EXPORT CATHETER TO CHECK FOR OBSTRUCTION AND NO OBSTRUCTION WAS DETECTED. AN IN HOUSE SYRINGE WAS ENGAGED TO THE HUB OF THE EXPORT CATHETER WHILE THE TIP WAS SUBMERGED INTO A BEAKER WITH WATER, THE SYRINGE PLUNGER WAS PULLED BACK AND WATER FILLED THE SYRINGE QUICKLY. THE LUMEN OF THE EXPORT MET SPECIFICATION.

    Description of Event or Problem · 1

    THE PHYSICIAN WAS TREATING A LESION IN THE RCA WHICH EXHIBITED MODERATE TORTUOSITY, MODERATE CALCIFICATION AND 70% LESION STENOSIS. THE EXPORT ASPIRATION CATHETER WAS REMOVED FROM THE PACKAGING PER IFU, THE DEVICE WAS INSPECTED AND REPORTED TO BE OK. IT WAS REPORTED THAT THE DEVICE WAS NOT PREPPED PER IFU. THE ARTERY DIAMETER WAS RECORDED AS 4.0MM WITH A LESION LENGTH OF 28MM. IT WAS REPORTED THAT THE ASPIRATION CATHETER WAS DAMAGED DURING USE AND COULD NOT ASPIRATE PROPERLY. IT WAS VERY DIFFICULT TO REMOVE THE DEVICE FROM THE PATIENT. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THIS EVENT. NO CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    339160 EXPORT AP ASPIRATION CATHETER CATHETER, EMBOLECTOMY DXE MEDTRONIC, INC 0007058893

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR