BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEXOR ANSEL GUIDING SHEATH

    MDR report key: 7046816 · Received November 20, 2017

    Report

    Report Number
    1820334-2017-04010
    Event Type
    Malfunction
    Date Received
    November 20, 2017
    Report Date
    March 2, 2018
    Manufacturer
    COOK INC
    Product Code
    DYB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RPN RECEIVED ON 14 NOV 2017: COMMON NAME & PRODUCT CODE UPDATED. PMA/510(K) NUMBER = PREAMENDMENT. INVESTIGATION - EVALUATION: A REVIEW OF THE DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. NUMEROUS DESIGN VERIFICATION AND VALIDATION ACTIVITIES HAVE BEEN PERFORMED TO ENSURE THAT THIS DEVICE MEETS DESIGN REQUIREMENTS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER FOR THE DEVICE WAS NOT AVAILABLE. A COMPLAINT HISTORY SEARCH WAS ALSO UNABLE TO BE PERFORMED DUE TO THE LACK OF A LOT NUMBER. FLEXOR ANSEL SHEATHS ARE SHIPPED WITH INSTRUCTIONS FOR USE (IFU) WHICH STATE, "THE MAXIMUM DIAMETER OF THE INSTRUMENT OR CATHETER TO BE INTRODUCED SHOULD BE DETERMINED TO ENSURE ITS PASSAGE THROUGH THE INTRODUCER. ALL INSTRUMENTS OR CATHETERS USED WITH THIS PRODUCT SHOULD MOVE FREELY THROUGH THE VALVE AND SHEATH. DAMAGE TO THE VALVE/INTRODUCER MAY RESULT WHEN THE FIT IS TIGHT. SHEATH INTRODUCTION: USING THE SIDE-ARM OF THE VALVE, FLUSH THE INTRODUCER BY FILLING THE INTRODUCER ASSEMBLY COMPLETELY WITH HEPARINIZED SALINE. FLUSH THE DILATOR WITH HEPARINIZED SOLUTION. INSERT THE DILATOR COMPLETELY INTO THE INTRODUCER." BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE 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.

    Additional Manufacturer Narrative · 1

    COMMON NAME & PRODUCT CODE = UNAVAILABLE AS DEVICE LOT, RPN, GPN ARE UNKNOWN. PMA/510(K) NUMBER = UNAVAILABLE AS DEVICE LOT, RPN, GPN ARE UNKNOWN. (B)(4). THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ANGIOGRAM, AIR BUBBLES WERE NOTICED IN THE CONTRAST MEDIA. AFTER THIS WAS NOTED, THE PHYSICIAN FLUSHED THE FLEXOR ANSEL GUIDING SHEATH AFTER EVERY EXCHANGE, BEING CAREFUL NOT TO INDUCE AIR. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE FLEXOR ANSEL GUIDING SHEATH WITH NO ADVERSE EFFECTS TO THE PATIENT. ACCESS WAS GAINED VIA FEMORAL PLACEMENT GOING CONTRALATERAL; WIRES, CATHETERS AND BALLOONS WERE UTILIZED THROUGH THE SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    826406 FLEXOR ANSEL GUIDING SHEATH DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1