BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 2031991 · Received March 28, 2011

    Report

    Report Number
    3005099803-2011-01103
    Event Type
    Malfunction
    Date Received
    March 28, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE MODEL, CATALOG NUMBER OR LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4) RELATES TO (B)(4) FOR NO INFORMATION REGARDING THE CONDITION OF THE EXIT MARKER MATERIAL. 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 BALLOON DILATATION CATHETER WAS USED DURING A DILATATION PROCEDURE PERFORMED ON (B)(6) 2011 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING PREPARATION OUTSIDE THE PATIENT, AS THE USER WAS PASSING THE DEVICE THROUGH THE SCOPE, THE BLACK PORTION OF THE CATHETER AT THE PROXIMAL END OF THE BALLOON WAS VERY DIFFICULT TO PUT THROUGH THE SCOPE. THE BLACK PORTION OF THE CATHETER WAS SHAVED OFF SO THAT THE DEVICE FIT THROUGH THE WORKING CHANNEL OF THE SCOPE. GIVEN THE BLACK PORTION OF THE CATHETER WAS VERY DIFFICULT TO PUT THROUGH THE SCOPE, IT IS POSSIBLE THE EXIT MARKER WAS LOOSE OR BUNCHED; THEREFORE THIS HAS BEEN DEEMED AN MDR REPORTABLE EVENT. THE PROCEDURE WAS COMPLETED WITH THIS CRE BALLOON DILATATION CATHETER. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THIS EVENT HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER INFORMATION IS RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    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 UNK99

    Patients

    Seq Age Sex Outcome Treatment
    1