BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH PKGD: WEDGE 6 FR 110 CM

    MDR report key: 4223231 · Received October 27, 2014

    Report

    Report Number
    3010532612-2014-00029
    Event Type
    Injury
    Date Received
    October 27, 2014
    Date of Event
    October 7, 2014
    Report Date
    October 7, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K892530
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHILE IN THE CATH LAB THE M.D. INSERTED THE WEDGE PRESSURE CATHETER. AFTER THE PROCEDURE, THE BALLOON WOULD NOT DEFLATE AND AS A RESULT, THE M.D. MANEUVERED IT OUT OF THE PATIENT'S VESSEL. THE REMOVAL OF THE WEDGE PRESSURE BALLOON FROM THE PATIENT TOOK 15 MINUTES. ACCORDING TO THE REPORT, THE BALLOON WAS STILL INFLATED AFTER REMOVAL. THERE WAS NO ATTEMPT TO USE ANOTHER ARROW WEDGE PRESSURE CATHETER. THERE WAS NO REPORTED PATIENT DEATH. ADDITIONAL INFORMATION RECEIVED ON 10/10/2014 STATED THE CATHETER WAS PRE-TESTED SUCCESSFULLY PRIOR TO INSERTION. THE M.D. DID HAVE TO CUT DOWN AT THE INSERTION SITE TO REMOVE THE WEDGE PRESSURE CATHETER FROM THE SUBCLAVIAN INSERTION SITE. THE M.D. HAS USED THE AI-07126 MANY TIMES BEFORE AND WAS NOT WILLING TO USE ANOTHER ARROW WEDGE PRESSURE CATHETER AGAIN. AT THIS TIME THE PATIENT APPEARED TO BE OKAY HOWEVER, THE M.D. AND STAFF WAS NOT WILLING TO SAY THIS EVENT DID NOT AND / OR WILL NOT HAVE A NEGATIVE IMPACT ON THIS PATIENT. THE M.D. WOULD NOT STATE THAT THE PATIENT WAS NOT INJURED DUE TO THIS EVENT. THE INTERVENTION WAS THE STRESS OF MANEUVERING TO GET THE INFLATED BALLOON OUT OF THE PATIENT'S RIGHT ATRIUM OF HIS HEART, THE RIGHT VENTRICLE AND OUT OF THE PULMONARY ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    681082 CATH PKGD: WEDGE 6 FR 110 CM BALLOON WEDGE PRESSURE CATHETER DYG ARROW INTERNATIONAL INC. 16F14E0048

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Hospitalization| R