BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER

    MDR report key: 7225685 · Received January 29, 2018

    Report

    Report Number
    1820334-2018-00206
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    January 22, 2018
    Report Date
    April 24, 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

    H6 METHOD CODE: SIMULATED USE TESTING (3345). INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE NOTED NO SURFACE DEFECTS OR OTHER BALLOON IRREGULARITIES. HOWEVER, THE BALLOON WOULD NOT INFLATE DURING TESTING. LEAKAGE WAS NOTED AT THE DISTAL .035 PORT OF THE HUB OF THE DEVICE. 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 BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT 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. 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. H6 METHOD CODE: SIMULATED USE TESTING (3345). INVESTIGATION ¿ EVALUATION. A REVIEW OF THE DIMENSIONAL VERIFICATION, COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, SPECIFICATIONS, AND A VISUAL INSPECTION AND FUNCTIONAL EVALUATION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE NOTED NO SURFACE DEFECTS OR OTHER BALLOON IRREGULARITIES. HOWEVER, THE BALLOON WOULD NOT INFLATE DURING TESTING. LEAKAGE WAS NOTED AT THE DISTAL .035 PORT OF THE HUB OF THE DEVICE. 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 BE NOTED THERE WAS ONE OTHER REPORTED COMPLAINT 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. 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.

    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 A SHUNT DILATATION FOR THE PATIENT'S LEFT ARM, THE ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER WAS OBSERVED TO BE LONGITUDINALLY RUPTURED DURING INFLATION. NO PRESSURE WAS APPLIED DURING INFLATION. THE PATIENT'S VESSEL WAS NOTED TO BE ANGULATED. ANOTHER MANUFACTURER'S 7 FR SHEATH, AND A WIRE GUIDE WERE UTILIZED DURING THE EVENT. 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
    68010 ADVANCE ENFORCER 35 FOCAL FORCE PTA BALLOON CATHETER PNO COOK INC G35252 10827002352527

    Patients

    Seq Age Sex Outcome Treatment
    1