BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE PULMONARY BALLOON DILATATION CATHETER

    MDR report key: 2024324 · Received March 18, 2011

    Report

    Report Number
    3005099803-2011-00821
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 18, 2011
    Report Date
    February 24, 2011
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KTI
    PMA / PMN Number
    K023337
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION FROM THE ACCOUNT REPORTED THAT THE BALLOON BURST. THE EXACT PRESSURE TO WHICH THE BALLOON WAS INFLATED IS UNKNOWN, HOWEVER IT WAS REPORTED THE BALLOON BURST AT A DIAMETER OF EITHER 15MM, 16.5MM, OR 18MM. NO OTHER VISIBLE ISSUES WERE NOTED TO THE DEVICE. THE BALLOON WAS INFLATED USING SALINE AND NO SHARP OBJECTS WERE IN THE AREA OF DILATION. PRELIMINARY DEVICE EVALUATION: VISUAL EVALUATION AND FUNCTIONAL TESTING OF THE RETURNED COMPLAINT DEVICE REVEALED A SMALL HOLE IN THE BALLOON PORTION OF THE DEVICE, INDICATING THE BALLOON DID NOT BURST DURING THE PROCEDURE. NO VISIBLE DEFECTS WERE NOTED TO THE CATHETER OF THE DEVICE. IT WAS CONFIRMED THE CORRECT DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THIS IS NOW NOT AN MDR REPORTABLE EVENT. IT IS MOST LIKELY THAT PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMITED THE PERFORMANCE OF THE BALLOON. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). 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 COOPERATION ON (B)(6) 2011 THAT A CRE PULMONARY BALLOON DILATATION CATHETER WAS USED DURING A FLEXIBLE BRONCHOSCOPY PROCEDURE ON (B)(6) 2011 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BROKE INSIDE THE PATIENT. NO PIECES DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON DILATATION CATHETER AND THE SAME INFLATION SYSTEM (UNKNOWN MODEL/UPN). THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE NATURE OF THE REPORTED DEFECT THAT THE BALLOON BROKE, HAVE BEEN UNSUCCESSFUL. IF ANY FURTHER 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 PULMONARY BALLOON DILATATION CATHETER WAS USED DURING A FLEXIBLE BRONCHOSCOPY PROCEDURE ON (B)(6), 2011 (PATIENT AGE, GENDER AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON BROKE INSIDE THE PATIENT. NO PIECES DETACHED. THE PROCEDURE WAS COMPLETED WITH ANOTHER CRE PULMONARY BALLOON DILATATION CATHETER AND THE SAME INFLATION SYSTEM (UNKNOWN MODEL/UPN). THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN FURTHER INFORMATION REGARDING THE NATURE OF THE REPORTED DEFECT THAT THE BALLOON BROKE, 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 PULMONARY BALLOON DILATATION CATHETER BRONCHOSCOPE ACCESSORY KTI BOSTON SCIENTIFIC - CORK M00550310 13883579

    Patients

    Seq Age Sex Outcome Treatment
    1 INFLATION SYSTEM (UNK MODEL/UPN)