BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CXI SUPPORT CATHETER

    MDR report key: 9774607 · Received March 2, 2020

    Report

    Report Number
    1820334-2020-00521
    Event Type
    Malfunction
    Date Received
    March 2, 2020
    Date of Event
    February 19, 2020
    Report Date
    June 9, 2020
    Manufacturer
    COOK INC
    Product Code
    KRA
    UDI-DI
    00827002525436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. ADDITIONAL INFORMATION: B5. H3: DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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

    SUMMARY OF EVENT: AS REPORTED, DURING AN ANGIOPLASTY PROCEDURE OF THE LEG VIA FEMORAL ACCESS, A CXI SUPPORT CATHETER HUB SEPARATED FROM THE DEVICE. THE DEVICE SEPARATION OCCURRED DURING THE "MIDDLE" OF THE PROCEDURE. NO RESISTANCE WAS REPORTED DURING DEVICE INSERTION OR REMOVAL, AND THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION, AS WELL AS A VISUAL INSPECTION OF THE COMPLAINT DEVICE. PHYSICAL EXAMINATION OF THE COMPLAINT DEVICE CONFIRMED THE CATHETER WAS RETURNED WITH THE HUB SEPARATED. BIOMATTER WAS PRESENT. THE DEVICE IS CRIMPED/BENT AT 5CM, 16.5CM, 19CM AND 39.5CM FROM THE PROXIMAL END. THE PROXIMAL END OF THE CATHETER WAS CLEAN WITH NO DAMAGE. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. THE COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, AND MANUFACTURING DOCUMENTS PROVIDE OBJECTIVE EVIDENCE THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NONCONFORMING DEVICES FROM THE COMPLAINT LOT IN HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IFU WARNS: WARNS, "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT THE CAUSE OF THE EVENT CAN BE TRACED TO A COMPONENT FAILURE WITHOUT A MANUFACTURING OR DESIGN DEFICIENCY. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ACTION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED 25FEB2020. AS REPORTED, A LEG ANGIOPLASTY WAS PERFORMED VIA FEMORAL ACCESS. THE DEVICE SEPARATION OCCURRED DURING THE "MIDDLE" OF THE PROCEDURE. NO RESISTANCE WAS REPORTED DURING DEVICE INSERTION OR REMOVAL, AND THE PATIENT'S ANATOMY WAS NOT TORTUOUS OR CALCIFIED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. 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.

    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

    OCCUPATION = NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K160884. 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 AN UNKNOWN PROCEDURE, A CXI SUPPORT CATHETER HUB SEPARATED FROM THE DEVICE. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238889 CXI SUPPORT CATHETER KRA CATHETER, CONTINUOUS FLUSH KRA COOK INC G52543 9933716 00827002525436

    Patients

    Seq Age Sex Outcome Treatment
    1