BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7869740 · Received September 12, 2018

    Report

    Report Number
    1820334-2018-02663
    Event Type
    Malfunction
    Date Received
    September 12, 2018
    Date of Event
    August 23, 2018
    Report Date
    November 6, 2018
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002309583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE(IFU), QUALITY CONTROL, SPECIFICATIONS, TRENDS, AND A FUNCTIONAL TEST & VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION AND FUNCTIONAL TEST OF THE RETURNED DEVICE CONFIRMED THAT THE SURFACE OF THE CATHETER WAS SMOOTH, CLEAN, AND NOT DAMAGED. BIOLOGICAL MATERIAL WAS NOTED INSIDE THE BALLOON AS WELL AS THE BALLOON PORT. THE CATHETER ACCEPTED A .018 WIRE WITHOUT DIFFICULT, AND THE LENGTH OF THE CATHETER WAS WITHIN SPECIFICATION. ADDITIONALLY, A PIN HOLE WAS NOTED DURING AN ATTEMPT TO INFLATE THE DEVICE TO NOMINAL PRESSURE. DUE TO THIS PIN HOLE, THE LENGTH AND DIAMETER OF THE BALLOON COULD NOT BE COMPLETED. 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. FURTHERMORE, AN IFU IS PROVIDED WITH THE DEVICE WHICH STATES ¿THE BALLOON IS MANUFACTURED FROM AN EXTRA-THINWALL, HIGH-STRENGTH, MINIMALLY-COMPLIANT MATERIAL. PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE.¿ IT GOES ON TO SAY "DO NOT EXCEED RATED BURST PRESSURE. RUPTURE OF BALLOON MAY OCCUR. ADHERE TO BALLOON INFLATION PRESSURE PARAMETERS IN THE COMPLIANCE CARD INSERT. OVER-INFLATION MAY CAUSE RUPTURE OF THE BALLOON, WITH RESULTANT DAMAGE TO THE VESSEL WALL. USE OF A PRESSURE GAUGE IS RECOMMENDED TO MONITOR INFLATION PRESSURES." MOREOVER, A REVIEW OF QUALITY CONTROL AND MANUFACTURES INSTRUCTIONS DID NOT REVEAL ANY GAPS. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. WE HAVE NOTIFIED THE APPROPRIATE PERSONNEL AND MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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 BALLOON PORTION OF THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER BURST WHEN BEING INFLATED INSIDE THE ARTERY DURING AN UNSPECIFIED PROCEDURE. ACCORDING TO THE COMPLAINANT, A PORTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT'S ANATOMY. NEITHER ADDITIONAL PROCEDURES NOR ADVERSE EFFECTS OCCURRED AS A RESULT OF THIS EVENT. ALTHOUGH REQUESTED, THE COMPLAINANT REPORTED NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711562 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC 8768031 10827002309583

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN RAABE SHEATH