BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, TRANSLUMINAL BALLOON

    MDR report key: 2190545 · Received August 4, 2011

    Report

    Report Number
    3005099803-2011-02606
    Event Type
    Malfunction
    Date Received
    August 4, 2011
    Date of Event
    July 8, 2011
    Report Date
    July 11, 2011
    Manufacturer
    BOSTON SCIENTIFIC - MARLBOROUGH
    Product Code
    GBA
    PMA / PMN Number
    K781772
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE REVEALED THE NEEDLE OF THE GAUGE TO BE STUCK AT 6PSI. THE LENS OF THE GAUGE WAS NOTED TO HAVE A YELLOWING APPEARANCE AND THE BULB AND TUBE WERE NOTED TO HAVE LOST THEIR SHINY APPEARANCE. STICKY RESIDUE WAS ALSO NOTED AROUND THE LENS OF THE GAUGE, POSSIBLY FROM REPEATED CLEANING. THE DATE CODE ON THE GAUGE WAS NOTICED DURING INSPECTION AND INDICATED THE GAUGE WAS MADE IN MAY OF 2000. FUNCTIONAL TESTING WAS PERFORMED; THE PRESSURE RELEASE VALVE WAS CLOSED AND THE AIR FLOW THROUGH THE LATEX TUBING WAS BLOCKED. THE RETURNED SAMPLE WAS PRESSURIZED TO 20 PSI, AND THE NEEDLE READ 20 PSI. HOWEVER, AFTER THE PRESSURE RELEASE VALVE WAS RELEASED, THE NEEDLE DID NOT RETURN TO THE 0PSI MARK; THEREFORE, THE PRODUCT DID NOT MEET SPECIFICATION. THE DEVICE WAS DISASSEMBLED AND THE NEEDLE WAS RESET. THE DEVICE WAS THEN RETESTED AND FUNCTIONED WITH NO ISSUES. BASED ON THE CONDITION OF THE RETURNED COMPLAINT DEVICE, THE REPORT THAT THE GAUGE WAS READING INACCURATELY WAS CONFIRMED. AS THE DEVICE WAS ASSEMBLED IN MAY 2000, IT IS LIKELY THE NOTED ISSUE ARE DUE TO REPEAT USE AND CLEANING OF THE DEVICE. THEREFORE, THE MOST PROBABLE ROOT CAUSE FOR THIS COMPLAINT IS WEAR AND TEAR.

    Additional Manufacturer Narrative · 1

    PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN. THE COMPLAINANT WAS UNABLE TO PROVIDE THE DEVICE LOT NUMBER. THEREFORE, THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. (B)(4). THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND 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 WAS USED DURING AN ACHALASIA DILATATION PROCEDURE OF THE CARDIA AND ESOPHAGUS PERFORMED ON (B)(6), 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER DILATATION, THE AIR WAS COMPLETELY REMOVED FROM THE RIGIFLEX BALLOON (BSC), HOWEVER THE GAUGE OF THE PUMP INDICATED 5PSI. IT WAS CONFIRMED THE BALLOON WAS COMPLETELY DEFLATED WHEN THE GAUGE INDICATED 5PSI. NO ISSUES WERE NOTED TO THE INFLATION DEVICE PRIOR TO THE PROCEDURE AND THERE WERE NO ISSUES WITH THE RIGIFLEX BALLOON. THE PROCEDURE HAD BEEN COMPLETED WITH THIS PNEUMATIC HAND PUMP PRIOR TO WHEN THE DEFECT WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT; THE EVENT HAD NO INFLUENCE ON THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2011 THAT A PNEUMATIC HAND PUMP WAS USED DURING AN ACHALASIA DILATATION PROCEDURE OF THE CARDIA AND ESOPHAGUS PERFORMED ON (B)(6) 2011. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, AFTER DILATATION, THE AIR WAS COMPLETELY REMOVED FROM THE RIGIFLEX BALLOON (BSC), HOWEVER THE GAUGE OF THE PUMP INDICATED 5PSI. IT WAS CONFIRMED THE BALLOON WAS COMPLETELY DEFLATED WHEN THE GAUGE INDICATED 5PSI. NO ISSUES WERE NOTED TO THE INFLATION DEVICE PRIOR TO THE PROCEDURE AND THERE WERE NO ISSUES WITH THE RIGIFLEX BALLOON. THE PROCEDURE HAD BEEN COMPLETED WITH THIS PNEUMATIC HAND PUMP PRIOR TO WHEN THE DEFECT WAS NOTED. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT; THE EVENT HAD NO INFLUENCE ON THE PATIENT'S CONDITION.

    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 RIGIFLEX BALLOON DILATOR (BSC)