BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 8228553 · Received January 8, 2019

    Report

    Report Number
    1820334-2019-00080
    Event Type
    Malfunction
    Date Received
    January 8, 2019
    Date of Event
    December 19, 2018
    Report Date
    March 13, 2019
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352572
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, OR UNAVAILABLE. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED, AND NO NONCONFORMING DEVICES HAVE BEEN IDENTIFIED IN HOUSE OR IN THE FIELD. THERE IS NO EVIDENCE THE PRODUCT WAS MANUFACTURED OUTSIDE OF CURRENT SPECIFICATIONS. A REPRESENTATIVE BALLOON PRODUCT FROM LOT NUMBER 9209468 WAS USED AS A REPRESENTATIVE DEVICE. THE PROCEDURE IN WHICH BOTH BALLOONS WERE USED WAS WITHIN A CALCIFIED LESION OF THE SUPERFICIAL FEMORAL ARTERY AND A BALLOON PRESSURE THAT DID NOT EXCEED THE RATED BURST PRESSURE. THE REPRESENTATIVE DEVICE SHOWED A LONGITUDINAL TEAR ALONG THE BALLOON MATERIAL. HOWEVER, THERE WAS NOTHING ON THE DEVICE THAT SUGGESTED THE PRODUCT WAS MANUFACTURED OUTSIDE OF CURRENT SPECIFICATIONS BASED ON THE INFORMATION PROVIDED, NO RETURNED PRODUCT AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE CAUSE COULD NOT BE ESTABLISHED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE = CATHETER, PERCUTANEOUS, CUTTING/SCORING, PNO. PMA/510(K) NUMBER = K141322. 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, AN ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS INFLATED FOR 90 SECONDS AT 10 ATMOSPHERES (ATM) IN A CALCIFIED LESION IN THE MALE PATIENT'S SUPERFICIAL FEMORAL ARTERY. AFTER THE 90 SECONDS, THE BALLOON RUPTURED. THE PERIPHERAL INTERVENTION PROCEDURE WAS ABLE TO BE COMPLETED WITH ANOTHER BALLOON. THE TYPE AND RATIO OF CONTRAST WAS UNKNOWN. THE PATIENT'S VESSEL WAS CALCIFIED BUT ANGULATION WAS NOT KNOWN. DIRECTION OF BALLOON RUPTURE (CIRCUMFERENTIAL OR LONGITUDINAL) WAS ALSO NOT KNOWN. 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. THE COMPLAINT DEVICE WILL NOT BE RETURNED TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21861 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35257 9209468 10827002352572

    Patients

    Seq Age Sex Outcome Treatment
    1