BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 8851929 · Received August 1, 2019

    Report

    Report Number
    1820334-2019-01896
    Event Type
    Injury
    Date Received
    August 1, 2019
    Date of Event
    April 18, 2019
    Report Date
    September 12, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY, DOCUMENTATION, DRAWING, SPECIFICATIONS, MANUFACTURER¿S INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE 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. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT NO CAUSE COULD BE ESTABLISHED FOR THE DEVICE FAILURE. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. 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

    PMA/510(K) NUMBER = K171275. (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 TO MANUFACTURER AND USER FACILITY DEVICE EXPERIENCE (MAUDE) THAT DURING AN UNKNOWN STENT PLACEMENT PROCEDURE, THE MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET'S WIRE GUIDE SEPARATED INSIDE OF A PATIENT. ACCESS WAS GAIN TO THE RIGHT POPLITEAL ARTERY USING A MODIFIED SELDINGER TECHNIQUE, DIRECT FLUOROSCOPIC, ULTRASOUND VISUALIZATION, AND THE MICROPUNCTURE SET. UPON ADVANCING THE SHEATH OVER THE COPE WIRE, THE FLOPPY TIP OF THE WIRE BUCKLED AND DURING REMOVAL, 6CM OF THE TIP SEPARATED AND REMAINED IN THE PATIENT. ATTEMPTS WERE MADE TO GRAB THE SEGMENT UNDER FLUOROSCOPY, BUT WERE UNSUCCESSFUL. ADDITIONAL ACCESS WAS GAIN THROUGH THE DISTAL PORTION OF THE RIGHT POPLITEAL ARTERY, AND A 7 FRENCH (FR.) SHEATH WAS PLACED WITHOUT DIFFICULTY TO DEPLOY THE STENT. A POST STENT ANGIOGRAPH REVEALED ADEQUATE STENT EXPANSION WITH NO EVIDENCE OF DISSECTION OR DISTAL EMBOLIZATION. NEAR THE END OF THE CASE, A SNARE WAS USED IN AN ATTEMPT TO RETRIEVE THE SEGMENT PORTION OF WIRE; HOWEVER, THIS WAS ALSO UNSUCCESSFUL. AT THIS POINT THE CARDIOVASCULAR SURGEON CALLED FOR A SURGICAL CUT DOWN TO REMOVE THE FOREIGN BODY. THE PATIENT WAS TRANSFERRED TO THE OPERATING ROOM WITH THE SHEATH LEFT IN AND A PRESSURE BAG TO PREVENT CLOTTING. A DIRECT CUT DOWN WAS PERFORMED AND THE WIRE TIP WAS LOCATED AND REMOVED IN ITS ENTIRETY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646836 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention