BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRE BALLOON DILATATION CATHETER

    MDR report key: 1952488 · Received January 7, 2011

    Report

    Report Number
    3005099803-2011-00013
    Event Type
    Malfunction
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 14, 2010
    Manufacturer
    BOSTON SCIENTIFIC - CORK
    Product Code
    KNQ
    PMA / PMN Number
    K971320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED NO DAMAGE TO THE CATHETER OF THE DEVICE, HOWEVER THE BALLOON PORTION OF THE DEVICE WAS FOUND TO BE TORN CIRCUMFERENTIALLY JUST BELOW THE DISTAL BALLOON BOND. VISUAL EXAMINATION OF THE BALLOON AND BALLOON BOND UNDER MAGNIFICATION CONFIRMED THE BALLOON TO BE TORN AS JAGGED EDGES OF THE BALLOON MATERIAL WERE CLEARLY VISIBLE. THE BOND WAS CONFIRMED TO BE INTACT AND CONTINUOUS; THERE WAS NO DEFECT OF THE BALLOON BOND. THEREFORE, THE COMPLAINT THAT THE BALLOON BOND SEPARATED WAS NOT CONFIRMED. HOWEVER, BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, BALLOON TORN CIRCUMFERENTIALLY, THIS COMPLAINT WILL REMAIN A REPORTABLE EVENT. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT THE PERFORMANCE OF THE BALLOON (E.G., THE BALLOON COMES INTO CONTACT WITH A SHARP EXTERIOR SOURCE). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT NO NON CONFORMANCES WERE RAISED FOR THE SPECIFIED LOT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT IS UNKNOWN. 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 WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON A (B)(6) OLD FEMALE PATIENT ON (B)(6), 2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE INFLATING THE BALLOON AT THE STRICTURE IN THE ESOPHAGUS, A SECTION OF THE BALLOON AT THE DISTAL END SEPARATED FROM THE CATHETER, AND A LEAK WAS NOTED AT THIS LOCATION. THE ACCOUNT REPORTED THE BALLOON BOND MAY NOT HAVE BEEN STRONG ENOUGH AT THE POINT WHERE THE BALLOON SEPARATED FROM THE CATHETER. IT WAS CONFIRMED THE BALLOON DID NOT BURST OR TEAR, AND NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. IN ADDITION, IT WAS REPORTED THE PRODUCT WAS NOT DAMAGED UPON REMOVAL FROM THE PACKAGING, NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE AND THE STERILE BARRIERS OF THE PACKAGE WERE NOT COMPROMISED. 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 STABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2010 THAT A CRE BALLOON DILATATION CATHETER WAS USED DURING A GASTROSCOPY PROCEDURE PERFORMED ON A (B)(6) FEMALE PATIENT ON (B)(6)2010 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE INFLATING THE BALLOON AT THE STRICTURE IN THE ESOPHAGUS, A SECTION OF THE BALLOON AT THE DISTAL END SEPARATED FROM THE CATHETER, AND A LEAK WAS NOTED AT THIS LOCATION. THE ACCOUNT REPORTED THE BALLOON BOND MAY NOT HAVE BEEN STRONG ENOUGH AT THE POINT WHERE THE BALLOON SEPARATED FROM THE CATHETER. IT WAS CONFIRMED THE BALLOON DID NOT BURST OR TEAR, AND NO PIECES OF THE BALLOON DETACHED INSIDE THE PATIENT. IN ADDITION, IT WAS REPORTED THE PRODUCT WAS NOT DAMAGED UPON REMOVAL FROM THE PACKAGING, NO DAMAGE WAS NOTED TO THE PACKAGING OF THE DEVICE AND THE STERILE BARRIERS OF THE PACKAGE WERE NOT COMPROMISED. 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 STABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CRE BALLOON DILATATION CATHETER DILATOR, ESOPHAGEAL KNQ BOSTON SCIENTIFIC - CORK M00558370 13325771

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR OLYMPUS GIF160 ENDOSCOPE, WORKING CHANNEL 2.8MM