BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR

    MDR report key: 1893407 · Received November 8, 2010

    Report

    Report Number
    3005099803-2010-04633
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    August 23, 2010
    Report Date
    October 19, 2010
    Manufacturer
    TECHDEVICE CORPORATION
    Product Code
    KNQ
    PMA / PMN Number
    K050232
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) FOR THE REPORTED EVENT OF BALLOON BURST. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED THE PRODUCT TO BE CLEAN, BUT THE BALLOON WAS SPLIT FROM THE PROXIMAL BOND TO THE DISTAL TIP, PROPAGATED 2/3RDS AROUND THE CIRCUMFERENCE OF THE DISTAL TIP AND THEN 1/3 BACK DOWN THE BALLOON ON THE OPPOSITE SIDE. THE DHR INDICATES THAT THE PRODUCTS WERE BUILT AND PACKAGED CORRECTLY PRIOR TO LEAVING TECH DEVICE. THERE WAS NO EVIDENCE OFF A MANUFACTURING DEFECT. THE CAUSE OF THE RUPTURE CANNOT BE DETERMINED. THERE WERE NO OTHER COMPLAINTS ON THIS LOT AND THE DHR SHOWED NO ANOMALIES.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RIGIFLEX II DILATATION BALLOON WAS USED DURING AN EGD (ESOPHAGOGASTRODUODENOSCOPY) PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINT, DURING PREPARATION FOR THE PROCEDURE THE RIGIFLEX WOULD NOT HOLD AIR AND IT WAS NOT USED IN THE PROCEDURE. A SECOND RIGIFLEX WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ON (B)(6) 2010 INVESTIGATION RESULTS REVEALED THAT THE BALLOON WAS TORN, INDICATING A BURST. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT HAS BEEN DESCRIBED AS "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR DILATOR, ESOPHAGEAL KNQ TECHDEVICE CORPORATION M00554520 0000061195

    Patients

    Seq Age Sex Outcome Treatment
    1 ACHALASIA PNEUMATIC HAND PUMP