BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACHALASIA BALLOON

    MDR report key: 882437 · Received July 20, 2007

    Report

    Report Number
    6000122-2007-00018
    Event Type
    Injury
    Date Received
    July 20, 2007
    Date of Event
    June 22, 2007
    Report Date
    June 22, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORK LTD.
    Product Code
    KNQ
    PMA / PMN Number
    K781772
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT INDICATED THAT THE DEVICE HAS BEEN DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE, AND WE ARE NOT ABLE TO DETERMINE THE RELATIONSHIP BETWEEN THIS DEVICE AND THE CAUSE FOR THIS EVENT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED ON THE PERTINENT LOT; NO ANOMALIES WERE NOTED. A SEARCH OF THE COMPLAINT DATABASE FOR SIMILAR COMPLAINTS WAS CONDUCTED; NO ADDITIONAL COMPLAINTS HAVE BEEN REPORTED FOR THE SAME LOT. THE MAY 2007 15-MONTH ACHALASIA BALLOON PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODELS WAS REVIEWED; NO ADVERSE TREND WAS NOTED.

    Description of Event or Problem · 1

    IN 2007, IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A LOWER ESOPHAGEAL SPHINCTER DILATATION PROCEDURE WAS PERFORMED, USING A 30MM RIGIFLEX II ACHALASIA BALLOON, ON A FEMALE PATIENT (AGE UNK). ACCORDING TO THE COMPLAINANT, THE PT HAD "REALLY NO STENOSIS - THE PATIENT HAD ACHALASIA PROVEN ON BARIUM X-RAY AND MANOMETRY, BUT THE UGIE WAS NORMAL WITH NO OBSTRUCTION TO THE PASSAGE OF THE ENDOSCOPE." THE LENGTH OF THE STENOSIS WAS A "TYPICAL BIRD'S BEAK ON BARIUM XR, RIGHT AT THE OGJ - I.E. A VERY SHORT STENOSIS." FOLLOW INFORMATION, OBTAINED FROM THE COMPLAINANT, ESTABLISHED THAT THE DILATATION PROCEDURE WAS PERFORMED AT PRESSURES RANGING FROM 12 TO 15 PSI, FOR APPROXIMATELY 1 MINUTE. IT WAS REPORTED THAT, "THE PT LATER PRESENTED WITH BACK PAIN." "BARIUM SWALLOW WAS CLEAR. CT SCAN SHOWED GAS PRESENT IN THE PATIENT'S CHEST." THE PHYSICIAN STATED, "PERFORATION WAS INCURRED DURING THE DILATATION." THE PHYSICIAN PLACED A BSC POLYFLEX STENT (21/25 X 12CM) TO "SEAL [THE] PERFORATION." THE PT WAS THEN RETURNED TO ICU. INFORMATION FROM THE NURSING STAFF REVEALED, "APPROXIMATELY 2 WEEKS POST STENT PLACEMENT, THE PT HAD A GASTROSCOPY, WHICH SHOWED THE STENT HAD SLIPPED SLIGHTLY' (DISTALLY) AND WAS SUBSEQUENTLY MOVED (PROXIMALLY) WITH BIOPSY FORCEPS." NO FURTHER INFO HAS BEEN OBTAINABLE REGARDING THE PATIENT'S CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACHALASIA BALLOON KNQ BOSTON SCIENTIFIC CORK LTD. M00554500 0000027688

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Required Intervention