BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FLEXOR RADIAL ACCESS SET

    MDR report key: 5784825 · Received July 12, 2016

    Report

    Report Number
    1820334-2016-00560
    Event Type
    Injury
    Date Received
    July 12, 2016
    Date of Event
    June 8, 2016
    Report Date
    March 20, 2017
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002355989
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K132592. INVESTIGATION - EVALUATION: CLINICAL IMAGING REVIEW: CLINICAL OPINION OF THE EVENT: IT WAS REPORTED THAT A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY AND THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. DUE TO THE AVAILABLE INFORMATION IT IS REASONABLE TO SUGGEST THAT THE ROOT CAUSE OF THE EVENT MIGHT BE ASSOCIATED WITH THE SURGICAL PROCEDURE AND/OR AN EVENTUAL MALFUNCTION OF THE DEVICE. A REVIEW OF THE COMPLAINT HISTORY, DRAWINGS, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. TWO USED (B)(4) SHEATHS WITH INSERTED DILATORS WERE RETURNED FOR INVESTIGATION. DURING VISUAL INSPECTION OF THE RETURNED COMPLAINT DEVICES, IT HAD BEEN OBSERVED THAT A SECTION OF THE SHEATHS' DISTAL TIPS HAD STARTED TO TEAR AND/OR BUCKLE BACKWARDS. ALSO, IT WAS FOUND THAT BOTH OF THE COMPLAINT DEVICES WERE MANUFACTURED WITH AN INADEQUATE TAPER, THE SHEATH'S DISTAL TAPER SHOULD BE GROUND 4-5 MM (UP TO, BUT NOT PAST, START OF COIL). WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED.

    Additional Manufacturer Narrative · 1

    BLANK FIELDS ON THIS REPORT INDICATE INFORMATION IS UNKNOWN OR UNAVAILABLE. PATIENT CODE: DAMAGE TO ARTERY IS NOT LABELED. DEVICE CODE: SPLIT AND DIFFICULT TO ADVANCE IS NOT LABELED. PMA/510(K) #: K132592. EVENT IS STILL UNDER INVESTIGATION AT THIS TIME.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT DURING A CARDIAC EXAMINATION/TREATMENT PROCEDURE ON THE FEMALE PATIENT, THE USER EXPERIENCED DIFFICULTY DURING USE OF THE FLEXOR RADIAL ACCESS DEVICE. THE REPORTER STATED THAT IT WASN'T POSSIBLE TO INSERT THE INTRODUCERS AS THEY SPLIT AND POPPED OPEN. IT WAS STATED THAT ALTHOUGH THE DEVICES WERE PROPERLY PREPARED AND USED, PER INSTRUCTION, THE FIRST 2 DEVICES THEY USED DIDN'T WORK; HOWEVER, THE 3RD ONE THEY TRIED WAS FINE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE TIP HURT THE ARTERY OF THE PATIENT FROM THE INSIDE; BUT NO FURTHER DETAILS WERE PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REQUESTED BUT AS OF REPORT DATE, NO INFORMATION HAS BEEN GIVEN.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT DURING A CARDIAC EXAMINATION/TREATMENT PROCEDURE ON THE FEMALE PATIENT, THE USER EXPERIENCED DIFFICULTY DURING USE OF THE FLEXOR RADIAL ACCESS DEVICE. THE REPORTER STATED THAT IT WASN'T POSSIBLE TO INSERT THE INTRODUCERS AS THEY SPLIT AND POPPED OPEN. IT WAS STATED THAT ALTHOUGH THE DEVICES WERE PROPERLY PREPARED AND USED, PER INSTRUCTION, THE FIRST 2 DEVICES THEY USED DIDN'T WORK; HOWEVER, THE 3RD ONE THEY TRIED WAS FINE. ADDITIONAL INFORMATION WAS PROVIDED THAT THE TIP HURT THE ARTERY OF THE PATIENT FROM THE INSIDE; BUT NO FURTHER DETAILS WERE PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REQUESTED BUT AS OF REPORT DATE, NO INFORMATION HAS BEEN GIVEN.

    Description of Event or Problem · 1

    INFORMATION WAS PROVIDED THAT DURING A CARDIAC EXAMINATION/TREATMENT PROCEDURE ON THE FEMALE PATIENT, THE USER EXPERIENCED DIFFICULTY DURING USE OF THE FLEXOR RADIAL ACCESS DEVICE. THE REPORTER STATED THAT IT WASN'T POSSIBLE TO INSERT THE INTRODUCERS AS THEY SPLIT AND POPPED OPEN. IT WAS STATED THAT ALTHOUGH THE DEVICES WERE PROPERLY PREPARED AND USED, PER INSTRUCTION, THE FIRST 2 DEVICES THEY USED DIDN'T WORK; HOWEVER, THE 3RD ONE THEY TRIED WAS FINE. THE TIP HURT THE ARTERY OF THE PATIENT FROM THE INSIDE; BUT NO FURTHER DETAILS WERE PROVIDED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION RECEIVED IDENTIFIED THE PATIENT RETURNED TO THE HOSPITAL DUE TO ARM INFLAMMATION ONE WEEK AFTER THE CARDIAC EXAMINATION/TREATMENT PROCEDURE. IT WAS STATED THAT, "THIS IS DEFINITELY NOTHING THAT CAN BE ASSIGNED ONLY TO THE SHEATH".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    440183 FLEXOR RADIAL ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 00827002355989

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R