BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FOLEY CATHETER W TEMP

    MDR report key: 8056962 · Received November 9, 2018

    Report

    Report Number
    2936999-2018-00679
    Event Type
    Malfunction
    Date Received
    November 9, 2018
    Report Date
    December 18, 2020
    Manufacturer
    MMJ SA DE CV (USD)
    Product Code
    DRF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS NOT SOLD IN US AND IS 510(K) EXEMPT. THIS REPORT IS ASSOCIATED TO A SIMILAR PRODUCT SOLD IN THE US - 510(K) NUMBER K831567. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS NOT RETURNED, BUT A PHOTO WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION OF THE PICTURE FOUND THE DEVICE WAS BROKEN. THE CONDITION OF THE CATHETERS DEFORMED SENSOR WIRE CAN OCCUR IF THE DEVICE WAS PULLED STRONGLY DURING USE. A RETAIN SAMPLE FROM THE SAME LOT WAS EXAMINED AND NO ISSUES WERE FOUND. IT WAS REPORTED THAT THE CATHETER BROKE. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    ACCORDING TO THE REPORTER, DURING A NORMAL USE, THE PATIENT HAD WORRYING MOVEMENT PATTERNS WHICH MOVED THE CATHETER AND BROKE. IT WAS REPORTED THAT 10 TO 15 CM OF THE CATHETER WAS STILL IN THE URETHRA OR BLADDER. CUSTOMER REPORTED THAT THE PATIENT WAS IN PALLIATIVE STATE; THUS, WAS DEEMED NOT APPROPRIATE FOR FURTHER ACTION. IT WAS INDICATED THAT THE PATIENT WAS DECEASED BUT THIS WAS NOT RELATED TO THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    897418 FOLEY CATHETER W TEMP CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING DRF MMJ SA DE CV (USD) 90055T S18006674

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR