BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7263852 · Received February 12, 2018

    Report

    Report Number
    1820334-2018-00398
    Event Type
    Malfunction
    Date Received
    February 12, 2018
    Date of Event
    January 29, 2018
    Report Date
    April 11, 2018
    Manufacturer
    COOK INC
    Product Code
    PNO
    UDI-DI
    10827002352527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DEVICE HISTORY RECORD, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER (ASB5-35-80-6-4) WAS RETURNED FOR INVESTIGATION. A DEVICE FAILURE ANALYSIS WAS CONDUCTED AND IT WAS FOUND THAT THE RETURNED DEVICE HAD A PINHOLE LEAK IN THE BALLOON 2.5CM FROM THE DISTAL TIP. THERE WAS NO DAMAGE TO THE CATHETER SHAFT OR BALLOON BONDS. THE DEVICE MEASURED WITHIN SPECIFICATION FOR CATHETER LENGTH. A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS NO NONCONFORMING EVENTS THAT COULD CONTRIBUTE TO THIS FAILURE MODE. A COMPLAINT HISTORY SEARCH REVEALED THAT THERE WERE TWO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITE ROOT CAUSE COULD NOT BE DETERMINED. PER THE [QUALITY ENGINEERING] RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. MONITORING WILL CONTINUE TO BE PERFORMED 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.

    Additional Manufacturer Narrative · 1

    COMMON NAME = CATHETER, PERCUTANEOUS, CUTTING/SCORING; PRODUCT CODE = PNO. PMA/510(K) NUMBER = K141322. (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 THAT DURING SHUNT DILATATION OF THE PATIENT'S LEFT ARM TO TREAT SUPERFICIAL FEMORAL ARTERY (SFA) LESION, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS UNABLE TO BE INFLATED AS IT WAS LONGITUDINALLY RUPTURED. NO PRESSURE WAS APPLIED TO THE BALLOON DURING THE EVENT. THE PATIENT'S ARTERIES WERE NOTED TO BE ANGULATED. ANOTHER MANUFACTURER'S SEVEN (7) FR SHEATH AND A WIRE GUIDE WERE IN PLACE DURING REMOVAL OF THE DEVICE. UPON BALLOON CATHETER WITHDRAWAL, A CLOCKWISE ROTATION OF THE BALLOON WAS NOT CONDUCTED. 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
    106663 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35252 10827002352527

    Patients

    Seq Age Sex Outcome Treatment
    1