BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7810330 · Received August 23, 2018

    Report

    Report Number
    1820334-2018-02450
    Event Type
    Malfunction
    Date Received
    August 23, 2018
    Date of Event
    August 1, 2018
    Report Date
    November 2, 2018
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343297
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE APPROPRIATE DATE HAS BEEN PROVIDED. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND FUNCTIONAL TEST & A 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 HUB WAS SMOOTH, CLEAN, AND NOT AT ALL DAMAGED. THE LENGTH OF THE CATHETER WAS 150.6CM, WHICH IS WITHIN SPECIFICATION. HOWEVER, DURING THE INFLATION ATTEMPT, A PIN HOLE LEAK WAS NOTED IN THE BALLOON 3.5CM FROM THE DISTAL END OF THE CATHETER. NO OTHER NONCONFORMANCES WERE NOTED. 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-THIN WALL, 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.¿ 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. THE FAULT LIKELY LIES WITH THE PATIENT CONDITION. 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.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION: B5: THIS EVENT OCCURRED DURING POST DILATION AFTER PLACEMENT OF A ZILVER STENT IN THE SFA. ACCORDING TO THE COMPLAINANT, THE COMPLAINT DEVICE RUPTURED DUE TO PLAQUE, AN ANGULATION IN ANATOMY AND ALIGNMENT OF THE STENT STRUT. IN THE COMPLAINANT'S OPINION, "A BALLOON ON A POINTED EDGE MOST LIKELY WOULD RUPTURE." 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.

    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.

    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 EXPERIENCED A RUPTURE WHEN IT CAME INTO CONTACT WITH THE "STRUT" OF A PREVIOUSLY PLACED STENT. THE PROCEDURE BEING PERFORMED WAS AN ANGIOPLASTY OF THE SUPERFICIAL FEMORAL ARTERY. THE RUPTURE OCCURRED DURING INFLATION, BEFORE NOMINAL PRESSURE WAS REACHED. A 50/50 MIXTURE OF VISIPAQUE WAS USED DURING THE PROCEDURE. IT WAS NOTED THAT THE PATIENT'S ANATOMY HAD BOTH ANGULATION AND CALCIFICATION. ONCE THE BALLOON RUPTURED, IT WAS REMOVED, AND ANOTHER DEVICE 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    651475 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G34329 8145661 10827002343297

    Patients

    Seq Age Sex Outcome Treatment
    1 ZILVER STENT (COOK)