BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSCATH SUPPORT CATHETER

    MDR report key: 8716190 · Received June 20, 2019

    Report

    Report Number
    1820334-2019-01486
    Event Type
    Malfunction
    Date Received
    June 20, 2019
    Date of Event
    June 10, 2019
    Report Date
    August 15, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002515802
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. REVIEWS OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT ONE CROSSCATH SUPPORT CATHETER WAS RETURNED TO COOK FOR INVESTIGATION. BIOMATTER WAS PRESENT THROUGHOUT THE DEVICE. A HOLE WAS NOTED 27.2CM FROM THE DISTAL TIP OF THE DEVICE. A STRESSED AREA WAS FOUND 28.5CM FROM THE DISTAL TIP OF THE DEVICE AND WAS 3MM IN LENGTH. KINKS WERE ALSO NOTED ON THE DEVICE AND WERE LOCATED AT 0.8CM, 1.4CM, 1.8CM, 2.3CM, AND 27.2CM FROM THE DISTAL TIP. THE HYDROPHILIC COATING WAS FOUND TO BE PRESENT ON THE DEVICE. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT ALSO SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH PROVIDES ALL THE PROPER INSTRUCTIONS, PRECAUTIONS, WARNINGS, INDICATIONS, AND CONTRAINDICATIONS. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER = K161801. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A PERIPHERAL INTERVENTION PROCEDURE INVOLVING A PATIENT OF UNKNOWN AGE AND GENDER, AN UNKNOWN MANUFACTURER'S "GLIDEWIRE" PUNCTURED A PREVIOUSLY KINKED CROSSCATH SUPPORT CATHETER. THE CATHETER WAS REPORTEDLY ADVANCED THROUGH A COOK 7 FRENCH BALKIN SHEATH OVER THE UNKNOWN WIRE IN AN ATTEMPT TO CROSS A CHRONIC TOTAL OCCLUSION (CTO) IN THE COMMON FEMORAL ARTERY. THERE WAS AN ANGLE "BEFORE" THE CTO THAT CAUSED THE CATHETER TO KINK. THE PHYSICIAN PULLED THE CATHETER OUT OF THE BODY AND STRAIGHTENED THE CATHETER. THE PHYSICIAN RE-INSERTED THE CATHETER OVER THE WIRE THROUGH THE SAME SHEATH. WHEN THE PHYSICIAN PULLED THE WIRE BACK AND ADVANCED IT AGAIN, THE WIRE PUNCTURED THROUGH THE SIDE OF THE CATHETER AT THE LOCATION OF THE ORIGINAL KINK. THE PHYSICIAN REMOVED THE DEVICE WHEN IT WAS OBSERVED THAT THE WIRE WAS NOT IN THE CATHETER. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513132 CROSSCATH SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G51580 9536010 00827002515802

    Patients

    Seq Age Sex Outcome Treatment
    1