BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 19074697 · Received April 9, 2024

    Report

    Report Number
    1820334-2024-00489
    Event Type
    Malfunction
    Date Received
    April 9, 2024
    Date of Event
    February 5, 2024
    Report Date
    July 1, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002074170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4- PMA/510(K) #: K171999. H3: (OTHER): THE DEVICE HAS BEEN RETURNED AND PRELIMINARY EVALUATION HAS BEEN PERFORMED; HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: IT WAS ORIGINALLY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, SHEATH PUNCTURE WITH THE PERFORMER INTRODUCER SET WAS USED TO ESTABLISH VENOUS ACCESS. AFTER OPENING, THE USER FOUND THAT THE WIRE GUIDE WAS KINKED AND COULD NOT BE USED. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON INITIAL EVALUATION OF THE RETURNED DEVICE ON 02APR2024, THE WIRE GUIDE COILS WERE FOUND TO BE ELONGATED. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), MANUFACTURING AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION WAS CONDUCTED AS WELL. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE WIRE WAS SHOWN TO BE BENT, ELONGATED, AND PARTIALLY UNRAVELED JUST BEFORE THE MIDPOINT SOLDER JOINT ON THE DISTAL END WITH THE SAFETY WIRE WAS STILL ATTACHED ON BOTH TIP WELD. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A SUB ASSEMBLY WIRE GUIDE COMPONENT LOT RECORDS ONE RELEVANT NON-CONFORMANCE FOR OFFSET COILS A QUANTITY OF TWO. HOWEVER, ALL NON-CONFORMING PRODUCT WAS SCRAPPED PRIOR TO RELEASE AND THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THIS NON-CONFORMANCE. AT THIS TIME, COOK HAS CONCLUDED THAT NO NON-CONFORMING PRODUCT FROM THIS LOT EXISTS IN HOUSE OR IN THE FIELD. THE PRODUCT IFU CONTAINS NO RELEVANT INFORMATION THE USER COULD FOLLOW TO PREVENT THIS FAILURE FROM OCCURRING. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, RETURNED PRODUCT, AND COMPLAINT FILE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THERE IS NO EVIDENCE OF NON-CONFORMING DEVICES IN-HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK CONCLUDED THAT A COMPONENT FAILURE CAUSED THIS INCIDENT AS IT IS MOST LIKELY OCCURRED DURING REMOVAL FROM THE HOLDER. THE RISK ANALYSIS FOR THIS FAILURE MODE WAS REVIEWED AND NO ADDITIONAL ESCALATION WAS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND COOK WILL CONTINUE TO MONITOR FOR SIMILAR EVENTS. 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

    IT WAS ORIGINALLY REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, SHEATH PUNCTURE WITH THE PERFORMER INTRODUCER SET WAS USED TO ESTABLISH VENOUS ACCESS. AFTER OPENING, THE USER FOUND THAT THE WIRE GUIDE WAS KINKED AND COULD NOT BE USED. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON INITIAL EVALUATION OF THE RETURNED DEVICE ON (B)(6) 2024, THE WIRE GUIDE COILS WERE FOUND TO BE ELONGATED.

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    498753 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB 15805979 00827002074170

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown