BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, TRANSLUMINAL BALLOON

    MDR report key: 1992148 · Received February 15, 2011

    Report

    Report Number
    3005099803-2011-00500
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Date of Event
    January 18, 2011
    Report Date
    January 18, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GBA
    PMA / PMN Number
    K781772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED SIGNS OF FOREIGN MATTER ON THE DIAL WHICH APPEARED TO BE REMNANTS OF CLEANING FLUID. NO VISIBLE DAMAGE OF THE DEVICE WAS NOTED. FUNCTIONAL TESTING WAS PERFORMED PER SPECIFICATION; THE DEVICE WAS MANUALLY INFLATED TO 20 PSI AND FUNCTIONED SUCCESSFULLY. THE ACCOUNT CONFIRMED THE CORRECT DEVICE WAS RETURNED FOR EVALUATION. BASED ON THE CONDITION OF THE RETURNED INCIDENT DEVICE, THE COMPLAINT THAT THE GAUGE WAS READING INACCURATELY WAS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE DATE IS UNKNOWN. (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 CORPORATION ON (B)(6), 2011 THAT A PNEUMATIC HAND PUMP AND RIGIFLEX ACHALASIA BALLOON WERE USED DURING AN ACHALASIA DILATATION PROCEDURE PERFORMED ON A 27 YEAR-OLD MALE PATIENT ON (B)(6), 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON INFLATED, HOWEVER IT WAS NOT POSSIBLE TO INCREASE THE PRESSURE PAST 5PSI. IT WAS CONFIRMED THE BALLOON DID INFLATE WHICH COULD BE SEEN UNDER X-RAY THEREFORE THE PROCEDURE WAS COMPLETED WITH THE SAME PNEUMATIC HAND PUMP AND THE SAME RIGIFLEX ACHALASIA BALLOON. AFTER THE PROCEDURE, INFLATION WAS ATTEMPTED OUTSIDE THE PATIENT WITH THE SAME PUMP AND BALLOON; AGAIN, IT WAS NOT POSSIBLE TO INCREASE THE PRESSURE PAST 5PSI AND AT THIS TIME, THE HANDLE OF THE PUMP SEEMED TO LEAK AIR. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE OR THE DEVICE PACKAGING. THE ACCOUNT ALSO REPORTED THE GAUGE OF THE PUMP WAS READING INACCURATELY, AND INDICATED A LOWER PRESSURE THAN THE DIAMETER TO WHICH THE BALLOON WAS INFLATED. THERE WAS NO ALLEGED MALFUNCTION OF THE RIGIFLEX ACHALASIA BALLOON USED IN THE PROCEDURE. 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) 2011 THAT A PNEUMATIC HAND PUMP AND RIGIFLEX ACHALASIA BALLOON WERE USED DURING AN ACHALASIA DILATATION PROCEDURE PERFORMED ON (B)(6) MALE PATIENT ON (B)(6) 2011 (PATIENT WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON INFLATED, HOWEVER IT WAS NOT POSSIBLE TO INCREASE THE PRESSURE PAST 5 PSI. IT WAS CONFIRMED THE BALLOON DID INFLATE WHICH COULD BE SEEN UNDER X-RAY THEREFORE THE PROCEDURE WAS COMPLETED WITH THE SAME PNEUMATIC HAND PUMP AND THE SAME RIGIFLEX ACHALASIA BALLOON. AFTER THE PROCEDURE, INFLATION WAS ATTEMPTED OUTSIDE THE PATIENT WITH THE SAME PUMP AND BALLOON; AGAIN, IT WAS NOT POSSIBLE TO INCREASE THE PRESSURE PAST 5 PSI AND AT THIS TIME, THE HANDLE OF THE PUMP SEEMED TO LEAK AIR. NO VISIBLE ISSUES WERE NOTED TO THE DEVICE OR THE DEVICE PACKAGING. THE ACCOUNT ALSO REPORTED THE GAUGE OF THE PUMP WAS READING INACCURATELY, AND INDICATED A LOWER PRESSURE THAN THE DIAMETER TO WHICH THE BALLOON WAS INFLATED. THERE WAS NO ALLEGED MALFUNCTION OF THE RIGIFLEX ACHALASIA BALLOON USED IN THE PROCEDURE. 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 CATHETER, TRANSLUMINAL BALLOON CATHETER, BALLOON TYPE GBA BOSTON SCIENTIFIC - MARLBOROUGH M00553200

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR RIGIFLEX ACHALASIA BALLOON (BSC, UNK UPN)