BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET

    MDR report key: 8716077 · Received June 20, 2019

    Report

    Report Number
    1820334-2019-01451
    Event Type
    Injury
    Date Received
    June 20, 2019
    Date of Event
    June 7, 2019
    Report Date
    September 23, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002480032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    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, DEVICE HISTORY RECORD, DOCUMENTATION, MANUFACTURING INSTRUCTIONS, QUALITY CONTROL PROCEDURES, AND A VISUAL INSPECTION OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE RETURNED DEVICE CONFIRMED SEPARATION OF THE OUTER CANNULA AT 4.2CM FROM THE TIP. A BUCKLE WAS ALSO OBSERVED IN THE SHEATH 2.3CM FROM THE TIP, AND THE TIP APPEARED TO HAVE BEEN PUSHED INWARD. NO OTHER ISSUES WERE IDENTIFIED DURING VISUAL ANALYSIS. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. FURTHERMORE, REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. AN ADDITIONAL INVESTIGATION WAS CONDUCTED BY THE SUPPLIER OF THE AFFECTED COMPONENT OF THE DEVICE. THE SUPPLIER REVIEWED THE MANUFACTURING RECORDS FOR THIS LOT AND CONCLUDED THAT THERE WERE NOT ANY DOCUMENTED ANOMALIES OR NON-CONFORMANCES REGARDING THE MANUFACTURING PROCESS FOR THE IDENTIFIED LOTS. THE SUPPLIER STATED THAT IT APPEARED THE SHEATH BUCKLED DURING THE PROCEDURE, WHICH MAY HAVE CREATED A STRESS POINT. WHEN THE DEVICE WAS REMOVED FROM THE PATIENT, THE FORCES REQUIRED TO EXTRACT THE DEVICE EXCEEDED THE CAPABILITY OF THE COMPROMISED TUBE STRENGTH. BASED ON THE INFORMATION PROVIDED AND THE EXAMINATION OF THE RETURNED PRODUCT, INVESTIGATION HAS CONCLUDED THAT THE MOST LIKELY CAUSE FOR THE DEVICE FAILURE WAS THE PATIENT¿S REPORTEDLY SCARRED ANATOMY NOT THE DEVICE ITSELF. 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

    OCCUPATION = LEAD TECH. 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

    AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A MALE PATIENT OF UNKNOWN AGE, THE 4 FRENCH (FR) SHEATH FROM A MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET SEPARATED UPON REMOVAL. THE LOWER ARM VENOUS ACCESS SITE WAS REPORTEDLY "VERY SCARRED". THE DEVICE WAS USED TO INJECT CONTRAST AND "TAKE PICTURES"; NO OTHER DEVICES WERE PASSED THROUGH THE SHEATH. THE USER REPORTED MEETING RESISTANCE DURING REMOVAL OF THE DEVICE, DESCRIBING IT AS "HESITATION". APPROXIMATELY FOUR CENTIMETERS OF THE OUTER CANNULA SEPARATED INTO THE PATIENT AND WAS ABLE TO BE RETRIEVED WITH A SNARE VIA ANOTHER ACCESS POINT. THE PHYSICIAN REPORTED THAT HE DID NOT CUT THE DEVICE; HOWEVER A STITCH WAS PLACED NEAR THE INTRODUCER. THE PHYSICIAN REPORTEDLY "THINKS HIS STITCH WAS FAR ENOUGH AWAY". A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    509810 MICROPUNCTURE TRANSITIONLESS STIFFENED CANNULA ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G48003 9658281 00827002480032

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention