BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 35 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8129286 · Received December 4, 2018

    Report

    Report Number
    1820334-2018-03503
    Event Type
    Malfunction
    Date Received
    December 4, 2018
    Date of Event
    November 6, 2018
    Report Date
    February 12, 2019
    Manufacturer
    COOK VASCULAR INC
    Product Code
    LIT
    UDI-DI
    10827002355368
    PMA / PMN Number
    K132020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CN
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL OF THE DEVICE WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, 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 SHOWS 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, A REVIEW OF THE DESIGN HISTORY FILE AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. MOREOVER, AN IFU IS PROVIDED WITH THE DEVICE, WHICH STATES INSTRUCTIONS TO INSPECT THE DEVICE UPON REMOVING IT FROM THE PACKAGE TO ENSURE NO DAMAGE AS OCCURRED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, INVESTIGATION HAS CONCLUDED THAT THIS DEVICE WAS LIKELY DAMAGED DURING TRANSPORT OR STORAGE OF THE DEVICE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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

    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 35 LP LOW PROFILE BALLOON CATHETER WAS FOUND TO BE KINKED IN THE MID-PART OF THE DEVICE WHILE STILL IN THE PACKAGE. SHARP EDGES WERE OBSERVED. ANOTHER BRAND OF BALLOON CATHETER WAS USED TO SUCCESSFULLY COMPLETE THE ANGIOPLASTY WITH STENTING PROCEDURE. THE COMPLAINT DEVICE NEVER MADE PATIENT CONTACT. NO ADVERSE EFFECTS WERE EXPERIENCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    969583 ADVANCE 35 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK VASCULAR INC G35536 NS8429903 10827002355368

    Patients

    Seq Age Sex Outcome Treatment
    1