BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 8426052 · Received March 15, 2019

    Report

    Report Number
    1820334-2019-00570
    Event Type
    Injury
    Date Received
    March 15, 2019
    Report Date
    June 20, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION - EVALUATION. REVIEWS OF THE COMPLAINT HISTORY AND PRODUCT DRAWINGS 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. IT SHOULD BE NOTED THAT THE PRODUCT LABELING DOES NOT PROVIDE DIMENSIONAL SPECIFICATIONS FOR THE LOCATION OF THE RADIOPAQUE MARKER BAND. HOWEVER, THE INITIAL REPORTER STATED THAT THE MARKER BAND ¿IS POSITIONED FEW MILLIMETERS AWAY¿ FROM THE DISTAL TIP OF THE DEVICE, WHICH IS THE CORRECT LOCATION PER PRODUCT SPECIFICATIONS. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT THIS COMPLAINT CAN BE TRACED TO MISUNDERSTANDING OF THE PRODUCT LABELING. PER OUR SPECIFICATIONS, AND THE IMAGE ON THE PRODUCT LABEL, THE MARKER IS IN THE CORRECT LOCATION (A FEW MILLIMETERS FROM THE DISTAL TIP). THE DISTRACT MANAGER HAS OFFERED TO DO AN IN-SERVICE WITH THE PHYSICIAN TO HELP CLARIFY THE MARKER LOCATION AND OVERALL DEVICE USE, BUT THE CUSTOMER DECLINED. 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 = PRE-AMENDMENT. 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, IN THE LAST YEAR THE COMPLAINANT FACILITY HAS EXPERIENCED SOME COMPLICATIONS WITH THE FLEXOR SHEATHS STOCKED IN THE LAB. ALL THE PROBLEMS WERE DIRECTLY CONNECTED TO THE POSITION OF THE RADIOPAQUE BAND AT THE TIP OF THE INTRODUCERS. IT HAS BEEN REPORTED THAT THE RADIOPAQUE BAND ISN'T AT THE VERY TIP OF THE LONG SHEATH, BUT IT IS POSITIONED A FEW MILLIMETERS AWAY AND THE VERY DISTAL TIP IS NOT SEEN WELL UNDER FLUOROSCOPY. ACCORDING TO THE INITIAL REPORTER, THIS HAS CAUSED SOME ADVERSE EVENTS INCLUDING: DISSECTION OF A VESSEL (REFER TO MEDWATCH 1820334-2019-00570 ), "CRUSH" OF A NEWLY PLACED STENT (REFER TO MEDWATCH 1820334-2019-00551) AND MISPLACEMENT OF A STENT (REFER TO MEDWATCH 1820334-2019-00552) BECAUSE THE OPERATOR DIDN'T REALIZE THE PROXIMAL SHOULDER OF THE BALLOON, WHERE THE STENT WAS MOUNTED, WAS STILL INSIDE THE LONG SHEATH. THIS REPORT CONCERNS THE DISSECTION OF A VESSEL. NO PATIENT/PRODUCT INFORMATION, EVENT DETAILS, PATIENT ANATOMY, TREATMENT OR OUTCOME INFORMATION WAS PROVIDED. DURING FOLLOW UP WITH THE COOK REPRESENTATIVE, IT WAS REPORTED THERE WERE REPEATED ATTEMPTS TO OBTAIN SUCH INFORMATION FROM THE TREATING PHYSICIAN WITHOUT SUCCESS BECAUSE THESE EVENTS TOOK PLACE OVER SEVERAL MONTHS AGO AND WERE NOT REPORTED TO THE MANUFACTURER OR MANUFACTURER'S REPRESENTATIVE AT THE TIME. THE COMPLAINT DEVICE IS NOT AVAILABLE FOR RETURN TO THE MANUFACTURER TO AID IN THE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218825 DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening