BEUDAMED
    FDA Adverse Event Other Summary report: N

    CCO CATHETER J-TIP

    MDR report key: 1923351 · Received November 18, 2010

    Report

    Report Number
    2025816-2010-00075
    Event Type
    Other
    Date Received
    November 18, 2010
    Date of Event
    October 17, 2009
    Report Date
    April 27, 2010
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: ALTHOUGH THE EXACT CAUSE(S) OF THE BALLOON TEARS/DAMAGES ARE UNKNOWN, THE ENGINEERING ANALYSIS REPORT CITES THIS TYPE OF DAMAGE HAS BEEN REPLICATED/CAN OCCUR AS A RESULT OF OVER-INFLATION OR PENETRATION WITH A SHARP INSTRUMENT/OBJECT. A REVIEW OF THE MFG LOT RECORDS FOR LOT# 72-801-R5 (MFG DATE 01/2009) SHOWS (B)(4) UNITS WERE MFG, TESTED INCLUDING 100 BALLOON TESTING, BURST STRENGTH, INSPECTED AND RELEASED. BASED ON THE RESULTS OF THIS COMPLAINT DEVICE INVESTIGATION, IT WAS THE MANUFACTURER'S RECOMMENDATION VIA COMPLAINT CLOSURE RESPONSE TO THE FACILITY CONTACT AND PRODUCT SERVICE SPCLTS THAT AN IN-SERVICE BE PERFORMED TO REVIEW THE CATHETER DEVICE INSTRUCTION FOR USE, DEVICE FEATURES AND PERFORMANCE PARAMETERS WITH THE FACILITY/STAFF.

    Description of Event or Problem · 1

    RESPONSE TO (B)(4), REPORTING MULTIPLE PROBLEMS WITH ONE 52510-12 CCO CATHETER. IT WAS REPORTED "SWAN NOT WEDGING, NO PA WAVE FORM, UNABLE TO FLUSH PA. MD NOTIFIED AND SWAN REPLACED. MD NOTED THE SWAN TO BE EXCEPTIONALLY HOT TO THE TOUCH AND THAT THE BALLOON WAS RUPTURED UPON REMOVAL." THE DEVICE WAS SUCCESSFULLY PRE-TESTED PRIOR TO PLACEMENT WITH NO PROBLEMS NOTED. LIMITED INFORMATION AVAILABLE AS TO THE LENGTH OF TIME THE DEVICE WAS IN USE, IDENTITY, MODEL AND SIZE OF ANCILLARY ACCESSORY DEVICES, SHEATHS, CONTAMINATION SHIELDS, TYPE OF MONITOR(S); CABLES, ETC. THERE WERE NO REPORTED ADVERSE PT CONSEQUENCES. MFR'S INVESTIGATION AND ANALYSIS: ONE USED 52510-12 CATHETER WAS RECEIVED AND PROCESSED. THE INVESTIGATION IS SUMMARIZED BELOW: VISUAL INSPECTION AND ANALYSIS WAS PERFORMED. THE CATHETER WAS RETURNED WITH A TOUCH CONTAMINATION SHIELD (MFG MAKE; MODEL, UNK) ATTACHED. THE CATHETER BALLOON WAS EXAMINED UNDER A MICROSCOPE WHERE IT WAS CONFIRMED THAT THE BALLOON WAS TORN. FUNCTIONAL TESTING WAS PERFORMED. CARDIAC OUTPUT, THERMISTOR ACCURACY TEST; CCO OUTPUT (MEASURED THE RESISTANCE VALUES OF THE COIL). THE RESULTS RECORDED NO OUT OF SPEC CONDITIONS, NON-CONFORMANCES. THE RETURNED DEVICE TESTING RECORDED ACCURATE PA MEASUREMENTS, CCO OUTPUT, AND LUMEN PATENCY TESTING WITH NO RESTRICTIONS FOUND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CCO CATHETER J-TIP CCO CATHETER J-TIP DYG ICU MEDICAL, INC. 52510-12 72-801-R5

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR CABLES| MONITOR| TOUCH CONTAMINATION SHIELD (MFG MAKE, MODEL, UNK)