BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KRA CATHETER, CONTINUOUS FLUSH

    MDR report key: 8399148 · Received March 7, 2019

    Report

    Report Number
    1820334-2019-00458
    Event Type
    Malfunction
    Date Received
    March 7, 2019
    Report Date
    April 29, 2019
    Manufacturer
    COOK INC
    Product Code
    KRA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B5: ADDITIONAL INFORMATION WAS RECEIVED FROM THE COOK REPRESENTATIVE ON 13MAR2019 REGARDING THE EVENT. THE PHYSICIAN WAS REFERRING TO TWO PATIENTS, TWO PROCEDURES. A TOTAL OF TWO CXI DEVICES MALFUNCTIONED, ONE IN EACH CASE. SPECIFIC LOT NUMBERS CANNOT BE OBTAINED AT THIS POINT. BOTH PROCEDURES WERE CENTRAL VENOUS OCCLUSION CASES, SPECIFICALLY ILIO-FEMORAL DEEP VEIN THROMBOSIS (DVT). THIS REPORT WILL ADDRESS DETAILS RECEIVED FOR PATIENT 1: THE ACCESS SITE FOR PATIENT 1 WAS THE MID-FEMORAL VEIN. THE PATIENT HAD CHRONIC DVT REGARDING ANATOMY. ACCORDING TO THE PHYSICIAN, THERE WAS NO DIFFICULTY ON INSERTION. UPON REMOVAL, THE COMPLAINT CATHETER REMOVED EASILY AND THE LAST 10 CM REMAINED ON THE WIRE. UPON REMOVING THE WIRE, THE TIP WAS DISCARDED. THE COMPLAINT DEVICE FRACTURED, MEANING THE TIP OF THE CATHETER SEPARATED FROM THE REST OF THE CATHETER. THE HUB DID NOT SEPARATE FROM THE SHAFT OF THE COMPLAINT DEVICE. NOTHING REMAINED IN THE PATIENT, AND THE OVERALL OUTCOME WAS SUCCESSFUL WITH RECANALIZATION WITH A NEW CXI CATHETER. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. REVIEWS OF THE DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. FURTHERMORE, REVIEWS OF THE QUALITY CONTROL PROCEDURES, DRAWING, AND TESTING & VALIDATION WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: THE CATHETER SHOULD NOT BE ADVANCED THROUGH AN AREA OF RESISTANCE UNLESS THE SOURCE OF RESISTANCE IS IDENTIFIED BY FLUOROSCOPY AND APPROPRIATE STEPS ARE TAKEN TO REDUCE OR REMOVE THE OBSTRUCTION. BASED ON THE LIMITED INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. 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

    ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. THIS INFORMATION IS DETAILED IN SECTION H10.

    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

    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

    A PHYSICIAN REPORTED A "COUPLE" CXI SUPPORT CATHETERS FRACTURED IN A PATIENT. LOT NUMBERS AND PRODUCT NUMBERS WERE NOT PROVIDED. PER THE PHYSICIAN, THIS EVENT HAPPENED "A WHILE AGO" AND HE CAN'T RECALL DETAILS. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE PHYSICIAN BUT HAS NOT YET BEEN RECEIVED. NO PATIENT ADVERSE EFFECTS HAVE BEEN REPORTED. THE COMPLAINT DEVICES WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191626 KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1