BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM TTC ESOPHAGEAL BALLOON DILATOR

    MDR report key: 2130018 · Received June 10, 2011

    Report

    Report Number
    1037905-2011-00403
    Event Type
    Injury
    Date Received
    June 10, 2011
    Date of Event
    May 12, 2011
    Report Date
    May 13, 2011
    Manufacturer
    WILSON-COOK MEDICAL INC
    Product Code
    KNQ
    PMA / PMN Number
    K935094
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO IN THIS REPORT WAS PROVIDED TO US BY THE COOK FACILITY IN (B)(4) ON BEHALF OF A MEDICAL FACILITY IN THE (B)(6). (B)(4). EVAL: A PRODUCT EVAL WAS NOT PERFORMED IN RESPONSE TO THIS REPORT BECAUSE THE PRODUCT SAID TO BE INVOLVED WAS NOT PROVIDED TO COOK FOR EVAL. THE REPORT COULD NOT BE CONFIRMED. THE DEVICE HISTORY RECORD FOR THE LOT NUMBER SAID TO BE INVOLVED WAS REVIEWED. A DISCREPANCY OR ANOMALY WAS NOT OBSERVED WITH THE PRODUCT THAT WAS RELEASED FOR DISTRIBUTION. A SAMPLE TEST FROM THIS LOT COULD NOT BE CONDUCTED BECAUSE NONE OF THE PRODUCT FROM THIS LOT REMAINED IN INVENTORY. A REVIEW OF THE COMPLAINT HISTORY WAS CONDUCTED. THERE HAVE BEEN NO OTHER SIMILAR OCCURRENCES DURING THE TIME PERIOD REVIEWED. THEREFORE, THIS REPORT REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF REPORT IS RARE. CONCLUSION: WE ARE UNABLE TO VERIFY THE REPORT BECAUSE THE PRODUCT COULD NOT BE EVALUATED. PRIOR TO DISTRIBUTION, ALL HERCULES 3 STAGE ESOPHAGEAL BALLOON DILATORS ARE SUBJECTED TO A VISUAL EXAMINATION TO ENSURE DEVICE INTEGRITY. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMED THAT THE LOT SAID TO BE INVOLVED MET ALL MFG REQUIREMENTS PRIOR TO SHIPMENT. CORRECTIVE ACTION: NO CORRECTIVE ACTION WARRANTED AT THIS TIME BECAUSE THE REPORT WAS UNABLE TO BE VERIFIED. THE COMPLAINT RISK PRIORITY NUMBER (CRPN) FOR THIS TYPE OF OCCURRENCE HAS BEEN CALCULATED BASED ON THE RATE OF OCCURRENCE AND SEVERITY OF THE OUTCOME. BASED ON THIS ACTIVITY, NO CORRECTIVE ACTION IS WARRANTED AT THIS TIME. THIS OBSERVATION REPRESENTS AN ISOLATED OCCURRENCE. THE LIKELIHOOD OF THIS TYPE OF OCCURRENCE IS RARE. CUSTOMER QA WILL CONTINUE TO MONITOR FOR COMPLAINT TRENDS.

    Description of Event or Problem · 1

    A COOK QUANTUM TTC ESOPHAGEAL BALLOON DILATOR WAS USED DURING THE PROCEDURE. THE TIP OF BALLOON REPORTEDLY WENT THROUGH THE WALL OF THE HIATUS HERNIA. PT WAS MONITORED IN THE HOSP FOR AN UNK AMOUNT OF TIME BEFORE BEING DISCHARGED. ACCORDING TO THE AREA REP, THE MEDICAL FACILITY HAS RECORDED THIS OCCURRENCE AS A PT INCIDENT. SEVERAL ATTEMPTS WERE MADE IN AN ATTEMPT TO COLLECT ADD'L INFO REGARDING PT IMPACT AND PRODUCT USAGE. THE COMPLAINANT DID NOT SPECIFY IF THE PT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THE REPORTED BALLOON TIP PENETRATION. THE COMPLAINANT DID NOT SPECIFY IF THE PT REQUIRED ADD'L MEDICAL PROCEDURES IN RESPONSE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 QUANTUM TTC ESOPHAGEAL BALLOON DILATOR KNQ, DILATOR, ESOPHAGEAL KNQ WILSON-COOK MEDICAL INC W2891895

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization ENDOSCOPE (UNK MAKE AND MODEL)