BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 8015036 · Received October 29, 2018

    Report

    Report Number
    1820334-2018-03293
    Event Type
    Malfunction
    Date Received
    October 29, 2018
    Report Date
    February 14, 2019
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL 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. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: THAT THE BALLOON CATHETER IS INTENDED FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY OF LESIONS IN PERIPHERAL ARTERIES, AND AS OBSTRUCTIVE LESIONS OF NATIVE OR SYNTHETIC ARTERIOVENOUS DIALYSIS FISTULAE. UPON OPENING AND REMOVING THE DEVICE, INSPECTION OF THE CATHETER IS REQUIRED TO ENSURE NO DAMAGE HAS OCCURRED DURING SHIPPING. THE USE OF THE DEVICE SHOULD BE SELECTED BASED ON THE APPROPRIATE LENGTH AND VESSEL DIAMETER. WHEN USING THE DEVICE, THE LABELING WARNS AGAINST INFLATING THE DEVICE PAST ITS RATED BURST PRESSURE. IF RUPTURE OR LOSS OF PRESSURE DOES OCCUR, THE INSTRUCTIONS INDICATE TO REMOVE THE BALLOON AND SHEATH AS A UNIT. FURTHERMORE, A REVIEW OF THE QUALITY CONTROL PROCEDURES WAS PERFORMED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE, BUT INSTEAD LIES WITH THE PATIENT¿S CONDITION AS TIGHTLY CALCIFIED STENOSIS WAS REPORTED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. 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

    COMMON NAME AND PRODUCT CODE = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS THE DEVICE LOT NUMBER, RPN, AND GPN ARE UNKNOWN. 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 UNSPECIFIED COOK ANGIOPLASTY BALLOON RUPTURED AND A PORTION OF THE BALLOON DETACHED DURING THE ANGIOPLASTY OF A CALCIFIED ILIAC LESION. THE DETACHED PORTION REMAINED ON THE GUIDE WIRE AND WAS ABLE TO BE SUCCESSFULLY RETRIEVED FROM THE PATIENT'S ANATOMY BY REMOVING THE WIRE GUIDE. DURING THE RETRIEVAL, THE GUIDE WIRE ACCESS WAS LOST AND A SECOND ARTERIAL PUNCTURE WAS REQUIRED (REFERENCE 1820334-2018-02584). ACCORDING TO THE INITIAL REPORTER, THIS IS THE SECOND TIME (REFERENCE THIS REPORT) A "COOK 0.018" ANGIOPLASTY BALLOON DEVICE WAS USED IN ATTEMPT TO CROSS A TIGHTLY CALCIFIED COMMON ILIAC ARTERY STENOSIS, AND ON BOTH OCCASIONS THE DEVICES RUPTURED AND SEPARATED. PRODUCT AND LOT NUMBERS WERE NOT PROVIDED. WITHOUT THIS INFORMATION, THE MANUFACTURING ADDRESS CANNOT BE DETERMINED. ADDITIONAL INFORMATION REGARDING THE DEVICE IDENTIFIERS AND COMPLAINT DEVICE AVAILABILITY HAS BEEN REQUESTED FROM THE COMPLAINANT. ADDITIONAL EVENT AND PATIENT OUTCOME INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    857708 UNKNOWN LIT UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1