BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 6 FR 90CM

    MDR report key: 4862383 · Received June 23, 2015

    Report

    Report Number
    3010532612-2015-00017
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 8, 2015
    Report Date
    June 8, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DYG
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    QN#(B)(4). EVALUATION: NO PRODUCT WAS RETURNED FOR EVALUATION. ACCORDING TO THE EVENT DETAILS, A 10ML SYRINGE WAS USED WITH THE PRODUCT. THE RECOMMENDED VOLUME CAPACITY OF THE BALLOON IS 1.0CC. AS A RESULT, THE BALLOON COULD HAVE POTENTIALLY RUPTURED FROM OVER-INFLATION OF THE BALLOON. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER/SERIAL NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: THE REPORTED COMPLAINT OF RUPTURED BALLOON IS NOT ABLE TO BE CONFIRMED. NO PRODUCT WAS RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CAG (CORONARY ANGIOGRAPHY) ROOM THE BERMAN CATHETER WAS PRE-TESTED SUCCESSFULLY. THE USER INSERTED THE CATHETER TO 50CM INTO THE PATIENT'S RIGHT VENTRICLE AND INFLATED THE BALLOON. AS THE USER TRIED TO ADVANCE THE CATHETER FURTHER THE BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED IN THE SAME SUBCLAVIAN VEIN. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED PATIENT DEATH, INJURY OR COMPLICATIONS. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY OR INTERRUPTION IN THERAPY. THE PATIENT OUTCOME IS LISTED AS GOOD. UPDATED INFORMATION RECEIVED ON (B)(6) 2015: THE SYRINGE USED WAS A 10ML SYRINGE. THE BALLOON WAS BEING INFLATED FOR THE FIRST TIME WHEN IT RUPTURED. THERE WERE NO RETAINED FRAGMENTS LEFT IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EVENT OCCURRED IN THE CAG (CORONARY ANGIOGRAPHY) ROOM THE BERMAN CATHETER WAS PRE-TESTED SUCCESSFULLY. THE USER INSERTED THE CATHETER TO 50CM INTO THE PATIENT'S RIGHT VENTRICLE AND INFLATED THE BALLOON. AS THE USER TRIED TO ADVANCE THE CATHETER FURTHER THE BALLOON RUPTURED. THE CATHETER WAS REMOVED AND REPLACED IN THE SAME SUBCLAVIAN VEIN. THE PROCEDURE WAS COMPLETED WITHOUT ANY PROBLEMS. THERE WAS NO REPORTED PATIENT DEATH, INJURY OR COMPLICATIONS. MEDICAL / SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY OR INTERRUPTION IN THERAPY. THE PATIENT OUTCOME IS LISTED AS GOOD. UPDATED INFORMATION RECEIVED ON 06/22/2015: THE SYRINGE USED WAS A 10ML SYRINGE. THE BALLOON WAS BEING INFLATED FOR THE FIRST TIME WHEN IT RUPTURED. THERE WERE NO RETAINED FRAGMENTS LEFT IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405200 CATH PKGD: BERMAN 6 FR 90CM ANGIOGRAPHIC CATHETER DYG ARROW INTERNATIONAL INC. 16F14K0018

    Patients

    Seq Age Sex Outcome Treatment
    1