BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 14117845 · Received April 15, 2022

    Report

    Report Number
    1820334-2022-00575
    Event Type
    Malfunction
    Date Received
    April 15, 2022
    Date of Event
    March 10, 2022
    Report Date
    June 16, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002211070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PMA/510(K) NUMBER: K171609. CUSTOMER NAME AND ADDRESS: PHONE: (B)(6). DEVICE EVALUATED BY MFG: 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.

    Additional Manufacturer Narrative · 0

    SUMMARY OF EVENT: AS INITIALLY REPORTED, DURING ANGIOGRAPHY VIA LEFT BRACHIAL ACCESS, THE WIRE INCLUDED WITH A PERFORMER INTRODUCER "RIPPLED UP" WHEN INSERTED THROUGH THE ACCESS NEEDLE AND COULD NOT BE ADVANCED. VESSEL SPASMS WERE NOT NOTED. THE WIRE WOULD NOT RETRACT. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE WIRE WAS UNRAVELED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, 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 IN A USED CONDITION. THE WIRE WAS UNRAVELED. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. ONE RELEVANT NON-CONFORMANCE WAS NOTED ON A SUBASSEMBLY LOT; HOWEVER, THE AFFECTED PRODUCT WAS SCRAPPED AND NOT REPLACED. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE PRODUCT IFU WARNS, ¿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 PROVIDES EVIDENCE THAT 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 HAS CONCLUDED THAT A COMPONENT FAILURE UNRELATED TO MANUFACTURING CONTRIBUTED TO THIS INCIDENT. 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 INITIALLY REPORTED, DURING ANGIOGRAPHY VIA LEFT BRACHIAL ACCESS, THE WIRE INCLUDED WITH A PERFORMER INTRODUCER "RIPPLED UP" WHEN INSERTED THROUGH THE ACCESS NEEDLE, AND COULD NOT BE ADVANCED. VESSEL SPASMS WERE NOT NOTED. THE WIRE WOULD NOT RETRACT. UPON RETURN AND INITIAL EVALUATION OF THE COMPLAINT DEVICE, THE WIRE WAS UNRAVELED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION HAS BEEN RECEIVED SINCE THE LAST REPORT WAS SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174816 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G21107 13791330 00827002211070

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Female