BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7915761 · Received September 27, 2018

    Report

    Report Number
    1820334-2018-02657
    Event Type
    Malfunction
    Date Received
    September 27, 2018
    Date of Event
    September 12, 2018
    Report Date
    January 16, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343327
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, QUALITY CONTROL, AND A FUNCTIONAL TEST & VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON HAD BIOMATTER ON BOTH INSIDE AND OUTSIDE OF THE DEVICE. NO VISUAL RUPTURE COULD BE SEEN DURING THE INITIAL VISUAL INSPECTION. THE BALLOON WAS INFLATED WITH WATER AND A PINHOLE LEAK TOWARDS THE MIDDLE OF THE BALLOON COULD BE SEEN. NO OTHER DAMAGE TO THE BALLOON CATHETER WAS OBSERVED. 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 SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES ¿THE BALLOON CATHETER IS INTENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF LESIONS IN PERIPHERAL ARTERIES, AND AS OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. UPON OPENING AND REMOVING THE DEVICE, INSPECTION OF THE CATHETER IS REQUIRED TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. THE USE OF THE DEVICE SHOULD BE SELECTED BASED ON THE APPROPRIATE LENGTH AND VESSEL DIAMETER.¿ FURTHERMORE, A REVIEW OF THE QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE BUT MAY INSTEAD LIE WITH THE PATIENT CONDITION AS CALCIFICATION WAS NOTED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. 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): K130293. 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

    IT WAS REPORTED, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER RUPTURED AT 10 ATMOSPHERES DURING AN UNSPECIFIED LEFT POPLITEAL PROCEDURE. THE VESSEL WAS CALCIFIED. ANOTHER BALLOON WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. 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. ALTHOUGH REQUESTED, NO INFORMATION WAS RECEIVED RELATIVE TO THE MIX OF CONTRAST TO SALINE, LESION LOCATION, OR VESSEL ANGULATION. NO INFORMATION WAS RECEIVED IF THE COMPLAINT DEVICE RUPTURED CIRCUMFERENTIALLY OR LONGITUDINALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    755395 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC 8900409 10827002343327

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR