BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE(TM) BALLOON DILATATION CATHETER

    MDR report key: 1935565 · Received December 22, 2010

    Report

    Report Number
    3005099803-2010-05290
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 3, 2010
    Report Date
    December 6, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KOG
    PMA / PMN Number
    K974788
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EXAMINATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DEFECTS TO THE CATHETER OR BALLOON PORTION OF THE DEVICE. FUNCTIONAL TESTING WAS PERFORMED AND THE BALLOON WAS SUCCESSFULLY INFLATED PER SPECIFICATION; NO DEFECTS OR MALFUNCTIONS OF THE DEVICE WERE IDENTIFIED. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THE BALLOON BURST WAS NOT CONFIRMED; HOWEVER, IT IS POSSIBLE THAT ANATOMICAL OR PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE CAUSED INFLATION DIFFICULTY. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    :ALTHOUGH THE SUSPECT DEVICE HAS BEEN RECEIVED, THE EVALUATION HAS NOT BEEN COMPLETED. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN DETERMINED. UPON COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED AT 2ATM. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT, AND THERE WAS NO MALFUNCTION OF THE ALLIANCE INFLATION SYSTEM USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 GOOD.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A CRE BALLOON DILATATION CATHETER AND ALLIANCE INFLATION SYSTEM WERE USED DURING AN ESOPHAGEAL DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON RUPTURED AT 2ATM. NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT, AND THERE WAS NO MALFUNCTION OF THE ALLIANCE INFLATION SYSTEM USED DURING THE PROCEDURE. THE PROCEDURE WAS COMPLETED WITH ANOTHER 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 GOOD.

    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 M00558450 13760466

    Patients

    Seq Age Sex Outcome Treatment
    1 ALLIANCE INFLATION SYSTEM (BSC)