BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 9296654 · Received November 8, 2019

    Report

    Report Number
    1820334-2019-02816
    Event Type
    Malfunction
    Date Received
    November 8, 2019
    Date of Event
    October 31, 2019
    Report Date
    December 3, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002503196
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES OF THE DEVICE 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 CONDUCTED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS FOUR NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. ALL NONCONFORMING DEVICES, HOWEVER, WERE IDENTIFIED AND SCRAPPED PRIOR TO FINAL INSPECTION. IT SHOULD ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWING, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT NO CAUSE COULD BE ESTABLISHED FOR THE DEVICE FAILURE. 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 RECEIVED 07NOV2019. AS REPORTED, THE DEVICE WAS USED THROUGH ANOTHER MANUFACTURER'S SHEATH. THE BALLOON RUPTURED AT THE SECOND INFLATION.

    Additional Manufacturer Narrative · 1

    (B)(6). PMA/510(K) NUMBER = K170193. 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 ENDOVENOUS THERAPY PROCEDURE INVOLVING A PATIENT WITH PERIPHERAL ARTERY DISEASE, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER RUPTURED. ACCESS WAS GAINED IN THE LEFT BRACHIAL ARTERY TO TREAT A LESION FROM THE LEFT POPLITEAL TO THE POSTERIOR TIBIAL ARTERY. ANOTHER MANUFACTURER'S 0.014 INCH WIRE GUIDE PASSED THROUGH THE LESION AND THE COMPLAINT DEVICE WAS ADVANCED OVER THE WIRE. REPORTEDLY, AS THE USER BEGAN TO INFLATE THE BALLOON, IT RUPTURED AT THE RATED BURST PRESSURE. ANOTHER DEVICE OF THE SAME TYPE WAS USED TO COMPLETE THE PROCEDURE. THE DEGREE OF CALCIFICATION AND TORTUOSITY WERE UNKNOWN, AS THE PATIENT'S KIDNEY FUNCTION WAS "NOT GOOD" TO USE CONTRAST MEDIA. THERE HAS BEEN NO REPORT THAT ANY PART OF THE DEVICE REMAINED IN THE PATIENT'S BODY, THAT THE PATIENT REQUIRED ANY ADDITIONAL PROCEDURES, OR THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1090736 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G50319 8483869 10827002503196

    Patients

    Seq Age Sex Outcome Treatment
    1 ASAHI INTECC'S GLADIUS 0.014 WIRE| MEDIKIT PARENT PLUS 60 SHEATH