BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7673630 · Received July 10, 2018

    Report

    Report Number
    1820334-2018-01619
    Event Type
    Malfunction
    Date Received
    July 10, 2018
    Date of Event
    July 3, 2018
    Report Date
    August 8, 2018
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002309583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED THAT THE BALLOON DID NOT RUPTURE. A PINHOLE LEAK WAS DISCOVERED IN THE BALLOON AT A DISTANCE OF 11.7 CM FROM THE DISTAL END OF THE DEVICE. BIOLOGICAL MATTER WAS ALSO NOTED IN THE BALLOON. 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 ONE NONCONFORMING EVENT WHICH COULD CONTRIBUTE TO THIS FAILURE MODE; HOWEVER, DUE TO THE INDIVIDUAL NATURE OF THE PRODUCT MANUFACTURING AND 100% VERIFICATION OF VARIOUS DEFECTS INCLUDING LEAK TESTING IN FINAL QC PRIOR TO SHIPPING, THERE IS NO INDICATION THAT THERE IS NONCONFORMING PRODUCT IN THE FIELD. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. 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. THE REPORTED FAILURE MODE WAS NOT OBSERVED DURING THE VISUAL INSPECTION OF THE DEVICE. 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/501K 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 BURST DURING A LEFT SUPERFICIAL FEMORAL ARTERY ANGIOPLASTY. THE DEVICE WAS INFLATED TO 6 ATMOSPHERES OF PRESSURE WITH AN "ISODUSE 50/50" SOLUTION WHEN IT EXPERIENCED THE RUPTURE. IT IS UNCLEAR IF THE RUPTURE WAS LONGITUDINAL OR CIRCUMFERENTIAL. THERE WAS NO ANGULATION, HOWEVER, HEAVY CALCIFICATION WAS NOTED. AFTER THE RUPTURE, THE DEVICE WAS REMOVED AND ANOTHER WAS USED SUCCESSFULLY. 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
    516361 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC 8345986 10827002309583

    Patients

    Seq Age Sex Outcome Treatment
    1