BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8422424 · Received March 14, 2019

    Report

    Report Number
    1820334-2019-00463
    Event Type
    Malfunction
    Date Received
    March 14, 2019
    Date of Event
    January 29, 2019
    Report Date
    April 29, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION REVIEWS OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT THE BALLOON CATHETER WAS RETURNED IN A USED STATE WITH BIOLOGICAL MATTER PRESENT THROUGHOUT THE DEVICE. THE BALLOON MATERIAL WAS FOUND TO BE SEPARATED AND THE CLEAR CATHETER SHAFT MATERIAL BELOW WAS FOUND TO BE ELONGATED. BOTH MARKER BANDS WERE PRESENT BUT NOT SECURE. 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 ALSO BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE QUALITY CONTROL PROCEDURES, DRAWING, AND OVERALL DESIGN HISTORY RECORD WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE WHICH STATES THE INTENDED USE OF THE DEVICE IS OUTLINED AS BEING DESIGNED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) OF LESIONS IN PERIPHERAL ARTERIES INCLUDING ILIAC, RENAL, POPLITEAL, INFRAPOPLITEAL, FEMORAL AND ILIOFEMORAL AS WELL AS OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. IT ALSO INCLUDES WARNINGS AGAINST EXCEEDING THE RATED BURST PRESSURE AND TO USE AN INFLATION DEVICE EQUIPPED WITH A PRESSURE GAUGE TO MONITOR THE INFLATION PRESSURES. IT ALSO ADVISES THAT IF BALLOON PRESSURE IS LOST AND/OR A BALLOON RUPTURE OCCURS, THE BALLOON IS TO BE DEFLATED AND REMOVED WITH THE SHEATH AS A UNIT. THERE IS NO INDICATION THAT THE DEVICE WAS USED IN A MANNER THAT WAS INCONSISTENT WITH THE PRODUCT LABELING. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THIS EVENT COULD NOT BE TRACED TO THE DEVICE BUT INSTEAD LIES WITH THE PATIENT¿S ANATOMY. REPORTEDLY, THE PATIENT¿S ANATOMY CONTAINED A ¿DISCREET ROCK ¿ WITH 95% CALCIFIED STENOSIS¿ 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

    ADDITIONAL INFORMATION IT WAS REPORTED THAT THE INITIAL COMPLAINT WAS FOR A BALLOON RUPTURE. THIS RESULTED IN THE DEVICE NOT HAVING THE CHANCE TO CROSS THE INTENDED AREA, AS ORIGINALLY REPORTED.

    Additional Manufacturer Narrative · 1

    OCCUPATION: NON-HEALTHCARE PROFESSIONAL. PMA/510(K) NUMBER = K130293. (B)(4). 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 WOULD NOT CROSS THE LESION. DURING PRELIMINARY VISUAL REVIEW OF THE RETURNED COMPLAINT DEVICE, IT WAS NOTED THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER IS RUPTURED/SEPARATED INTO PIECES. A (B)(6) FEMALE WITH A 95% CALCIFIED STENOSIS OF THE RIGHT ILIAC WAS UNDERGOING AN UNSPECIFIED PERIPHERAL INTERVENTION PROCEDURE. THE COMPLAINT BALLOON WAS BEING USED FOR PRE-DILATION OF A PROXIMAL ILIAC LESION THAT WAS DESCRIBED AS HAVING AN AREA LIKE "A DISCREET ROCK". THERE WAS ONE INSERTION OF THE BALLOON AND TWO INFLATIONS USING AN UNSPECIFIED MANUFACTURER'S INFLATION DEVICE AND AN INFLATION MEDIUM REPORTED AS ISOVUE 300 CONTRAST IN A 50/50 CONTRAST WITH SALINE. ANOTHER DEVICE IN USE AT THE TIME WAS ANOTHER MANUFACTURER'S FIVE FRENCH SHEATH. THE PATIENT'S ANATOMY WAS NEITHER ANGLED NOR TORTUOUS. THE COMPLAINT BALLOON WAS REMOVED "IN THE NORMAL FASHION". 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
    215530 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC G34323 8768830 10827002343235

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR