BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 2083502 · Received May 10, 2011

    Report

    Report Number
    3005099803-2011-01623
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 14, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. HOWEVER, IT WAS REPORTED THAT THE DEVICE WAS NOT USED PAST ITS EXPIRATION. (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF BALLOON BURST. ACCORDING TO THE COMPLAINANT, THE SUSPECT DEVICE HAS BEEN DISPOSED AND IS NOT AVAILABLE FOR RETURN. IF ANY FURTHER RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A CRE WIRE GUIDED BALLOON DILATATION CATHETER WAS USED DURING AN ESOPHAGEAL DILATION PREFORMED ON A (B)(6) MALE PATIENT (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINT, THE BALLOON WAS INFLATED TO A DIAMETER OF 18MM AND AT THE COMPLETION OF THE DILATATION, THE BALLOON BEGAN TO DEFLATE. THE COMPLAINANT WAS UNABLE TO CONFIRM WHETHER OR NOT THE BALLOON BURST. THE DEVICE WAS COMPLETELY DEFLATED AND TAKEN OUT OF THE PATIENT, HOWEVER THE BALLOON COULD NOT BE RE-INFLATED. IT WAS REPORTED THAT RESIDUE OF BLOOD WAS NOTED ON THE BALLOON. HOWEVER, NO INTERVENTION WAS REQUIRED AS THE PHYSICIAN WAS NOT CONCERNED WITH THE BLEEDING AND CONFIRMED IT WAS TYPICAL. NO VISIBLE ISSUES WERE NOTED TO THE BALLOON AND NO PIECES OF THE BALLOON WERE OBSERVED TO DETACH INSIDE THE PATIENT. THE DILATATION HAD BEEN COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THE EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE(TM) BALLOON DILATATION CATHETER ENDOSCOPE AND/OR ACCESSORIES, DILATOR, ESOPHAGEAL KOG BOSTON SCIENTIFIC - CORK M00558490

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR