BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 2992317 · Received March 1, 2013

    Report

    Report Number
    2242445-2013-00027
    Event Type
    Injury
    Date Received
    March 1, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 27, 2013
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT INVOLVED A PEDIATRIC PATIENT WHILE IN THE CATH LAB AND AFTER THE CATHETER WAS INSERTED. WHEN THEY WENT TO TAKE AN ANGIOGRAM, THE CATHETER INTRODUCED AIR INTO THE PATIENT AND CAUSED CARDIAC ISCHEMIA. AS A RESULT, THE CATHETER WAS REMOVED. IT IS UNKNOWN IF THERE WAS ANOTHER ATTEMPT AT THE PROCEDURE. THE PATIENT HAD COMPLICATIONS AND WAS INJURED (CARDIAC ISCHEMIA). ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2013 STATED THAT THE PATIENT DID NOT PASS AWAY BECAUSE OF THE CATHETER ISSUE. THE PATIENT GOT CARDIAC ISCHEMIA DUE TO THE AIR THAT WAS RELEASED INTO HIS BODY. THE MALE PATIENT WAS TREATED AND WAS FINE. THE BALLOON OF THE CATHETER WAS INFLATED AT THE TIME OF THE CONTRAST MEDIA INJECTION. THE PROBLEM OCCURRED WHEN THE BALLOON WAS INFLATED; IT ALSO PUSHED AIR THROUGH ONE OF THE CONTRAST MEDICAL HOLES THEREBY PUSHING AIR INTO THE PATIENT WHICH SEEMED TO BE THE SAME LUMEN USED TO INFLATE THE BALLOON. THE CATHETER WAS INFLATED WITH AIR WITH VOLUME .60 CC. WHEN THEY REMOVED THE CATHETER, THEY PROCEEDED TO INFLATE THE BALLOON OUTSIDE THE BODY. THEY WITNESSED THE BALLOON INFLATED, BUT ALSO AIR LEAKING FROM ONE OF THE CONTRAST MEDIA HOLES. VOLUME, PRESSURE SETTINGS AND BRAND/TYPE OF CONTRAST MEDIA WERE NOT AVAILABLE. THE PRODUCT WAS PRETESTED AND NO ISSUES WERE OBSERVED. IT WASN'T UNTIL THEY PULLED THE CATHETER OUT OF THE PATIENT AND INFLATED THE BALLOON AGAIN WHEN THEY OBSERVED THE AIR BUBBLES FROM ONE OF THE CONTRAST MEDIA HOLES WHERE BLOOD WAS COVERING THEM. THE INSERTION ITE WAS THE FEMORAL VEIN. THERE WAS NOT ANOTHER ATTEMPT AT THE PROCEDURE. IT IS UNKNOWN HOW LONG IT HAD BEEN INSERTED PRIOR TO THE ANGIOGRAM. THERE WAS A DELAY OR INTERRUPTION IN THERAPY WITH NO HARM TO THE PATIENT. THERE WAS NO REPORT OF PATIENT DEATH. THERE WAS NO MEDICAL/SURGICAL INTERVENTION REQUIRED. THE PATIENT OUTCOME WAS THE PATIENT WENT TO THE RECOVERY UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    89127 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF1126226

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other