BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 17316955 · Received July 13, 2023

    Report

    Report Number
    1820334-2023-00892
    Event Type
    Malfunction
    Date Received
    July 13, 2023
    Report Date
    October 18, 2023
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002096912
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    OCCUPATION (B)(6). PMA/510(K) NUMBER: K171999. DEVICE EVALUATED BY MFG = OTHER (81) - DEVICE EVALUATION HAS BEGUN; HOWEVER, A CONCLUSION IS NOT YET AVAILABLE. 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 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS REPORTED, UPON OPENING THE PACKAGE AND FLUSHING A PERFORMER INTRODUCER PRIOR TO USE, THE USER NOTICED THAT THE TIP OF THE DILATOR WAS DAMAGED, DESCRIBING THE DAMAGE AS "CHIPPED". THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE DILATOR WAS NOTED TO BE SPLIT. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE COMPLAINT DEVICE WAS RETURNED TO COOK FOR INVESTIGATION. THE DILATOR TIP WAS SPLIT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES OR ADDITIONAL COMPLAINTS WERE FOUND ON THE FINAL LOT. ONE RELEVANT NON-CONFORMANCE WAS NOTED ON THE DILATOR COMPONENT LOT; HOWEVER, ALL NON-CONFORMING PRODUCT WAS REWORKED, THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THE NON-CONFORMANCE, AND THERE HAVE BEEN NO ADDITIONAL COMPLAINTS ON ANY FINAL LOT CONTAINING THE SAME DILATOR COMPONENT LOT. THE PRODUCT IFU STATES ¿UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, IFU, AND INVESTIGATION OF THE RETURNED DEVICE SUGGESTS THAT THERE IS EVIDENCE THE DEVICE WAS MANUFACTURED TO SPECIFICATION. ALTHOUGH ONE RELEVANT NON-CONFORMANCE WAS NOTED ON THE DILATOR COMPONENT LOT, ALL NON-CONFORMING PRODUCT WAS REWORKED, THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THIS NON-CONFORMANCE, ADEQUATE INSPECTION ACTIVITIES HAVE BEEN ESTABLISHED, THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED, AND NO OTHER LOT-RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD. THEREFORE, IT WAS CONCLUDED THAT THERE IS NO EVIDENCE THAT ADDITIONAL NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT SHIPPING AND HANDLING OF THE DEVICE CONTRIBUTED TO THIS EVENT, AS THE CUSTOMER REPORTED THAT THE DILATOR TIP WAS DAMAGED UPON OPENING THE PACKAGE. 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

    AS REPORTED, UPON OPENING THE PACKAGE AND FLUSHING A PERFORMER INTRODUCER PRIOR TO USE, THE USER NOTICED THAT THE TIP OF THE DILATOR WAS DAMAGED, DESCRIBING THE DAMAGE AS "CHIPPED". THE DEVICE DID NOT MAKE PATIENT CONTACT. ANOTHER SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. UPON RETURN AND INITIAL EVALUATION OF THE DEVICE, THE TIP OF THE DILATOR WAS NOTED TO BE SPLIT.

    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
    2260199 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G09691 15405887 00827002096912

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown