BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PEEL-AWAY DENNY SHEATH INTRODUCER SET

    MDR report key: 9139726 · Received October 1, 2019

    Report

    Report Number
    1820334-2019-02468
    Event Type
    Injury
    Date Received
    October 1, 2019
    Date of Event
    August 20, 2019
    Report Date
    November 19, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002115682
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION EVALUATION . A REVIEW OF THE DOCUMENTATION INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS (MI), AND QUALITY CONTROL WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, THE COMPLAINANT RETURNED A DEVICE FOR THE SAME FAILURE MODE ON THE SAME RPN FOR A SIMILAR COMPLAINT. THE EVALUATION FOR THAT DEVICE CAN BE FOUND UNDER REPORT REFERENCE NUMBER 1820334-2019-02404. THIS COMPLAINT WAS ABLE TO BE CONFIRMED BASED ON CUSTOMER TESTIMONY. THERE IS NO EVIDENCE THAT THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. AN ANALYSIS OF THE DESIGN HISTORY FILE INDICATES THAT THE RISKS ASSOCIATED WITH THE DEVICES IS ACCEPTABLE WHEN WEIGHED AGAINST THE BENEFITS. THE DEVICE HISTORY RECORD (DHR) FOR THE COMPLAINT LOT (9211124) AS WELL AS FOR THE WIRE GUIDE SUB-ASSEMBLY LOT (IC9168957) RECORDS NO NON-CONFORMANCES. A DATABASE SEARCH FOUND NO ADDITIONAL COMPLAINTS FOR THE COMPLAINT LOT. AS THERE ARE ADEQUATE INSPECTION ACTIVITIES ESTABLISHED, OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, NO NON-CONFORMANCES, AND NO ADDITIONAL COMPLAINTS FROM THE SAME LOT, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NONCONFORMING PRODUCT EXISTS IN HOUSE OR IN FIELD. COOK COULD NOT REVIEW THE PRODUCT LABELING BECAUSE NO IFU (INSTRUCTIONS FOR USE) EXISTS FOR RPN: PLIP-6.0-18-9-DENNY. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE CAN BE TRACED TO THE USER AS AN UNINTENDED USE ERROR CAUSING OR CONTRIBUTING TO THE EVENT. IT WAS REPORTED BY THE CUSTOMER THAT THE GUIDE WIRE WAS PULLED BACK FOR REPOSITIONING. THEREFORE, THE SOFT TIP GOT CAUGHT IN THE NEEDLE. THE GUIDE WIRE SHOULD NOT BE REMOVED THROUGH THE NEEDLE. PULLING THE GUIDE WIRE BACK TO REPOSITION CAN CAUSE THE WIRE GUIDE TO GET CAUGHT ON THE SHARP EDGE OF THE NEEDLE AND CAN CAUSE SEPARATION AND DAMAGE TO THE WIRE GUIDE. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, 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) #: NOT EXEMPT, PRE-AMENDMENT. (B)(4). A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INSERTION OF A TUNNELED CENTRAL LINE, AS THE WIRE GUIDE OF THE PEEL-AWAY DENNY SHEATH INTRODUCER SET WAS BEING PULLED BACK TO REPOSITION, THE SOFT TIP OFF THE WIRE GOT CAUGHT ON THE NEEDLE, UNFOLDED, AND FORMED A KNOT. DUE TO THE KNOT FORMATION, AN INCISION WAS REQUIRED TO BE MADE IN THE NECK OF THE PATIENT TO EXPOSE AND CONTROL THE INTERNAL JUGULAR VEIN. THE VEIN WAS THEN OPENED TO REMOVE THE KNOTTED GUIDE WIRE SAFELY. THE INCISION WAS SUTURED AND A THIRD ATTEMPT FOR INSERTION WAS MADE AT A DIFFERENT SITE. ANOTHER LIKE DEVICE FROM A DIFFERENT LOT EXPERIENCED A SIMILAR FAILURE DURING THE PROCEDURE. THAT DEVICE FAILURE WAS CAPTURED IN THE REPORT WITH MFG. REPORT REFERENCE #: 1820334-2019-02404. PATIENT INFORMATION INCLUDING DEMOGRAPHICS AND PRE-EXISTING CONDITIONS WAS NOT PROVIDED BY THE FACILITY. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME, AS WELL AS EVENT AND DEVICE DETAILS HAVE BEEN REQUESTED, BUT HAVE NOT BEEN MADE AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    933003 PEEL-AWAY DENNY SHEATH INTRODUCER SET DYB INTRODUCER, CATHETER DYB COOK INC N/A 9211124 00827002115682

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention