BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 13939450 · Received March 29, 2022

    Report

    Report Number
    1820334-2022-00479
    Event Type
    Injury
    Date Received
    March 29, 2022
    Date of Event
    March 16, 2022
    Report Date
    May 31, 2022
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K171275
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. PMA/510(K) NUMBER = ALTHOUGH THE EXACT RPN IS UNKNOWN, THE 510(K) FOR MPIS (MICROPUNCTURE) DEVICES IS EITHER K171275 OR K172980. 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

    D4- POSSIBLE LOTS, PER A SEARCH OF GLOBAL SALES DATA, ARE 14165168 OR 9599469. SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING RECANALIZATION OF THE POSTERIOR TIBIAL ARTERY, A WIRE INCLUDED IN AN UNSPECIFIED COOK MICROPUNCTURE SET SEPARATED IN THE PATIENT. ACCESS WAS OBTAINED IN THE POSTERIOR TIBIAL ARTERY AT THE ANKLE. THE ACCESS SITE WAS NOT SCARRED. THE WIRE WAS NOT PULLED BACK THROUGH THE ENTRY NEEDLE. THE ACCESS NEEDLE WAS REMOVED, AND THE SHEATH WAS INSERTED. AS THE USER ATTEMPTED TO REMOVE THE 0.018-INCH WIRE FROM THE SHEATH, THE WIRE SHEARED. PER THE USER, IT IS POSSIBLE THAT THE WIRE CAUGHT ON THE END OF THE SHEATH PRIOR TO SHEARING. THE SEPARATED DISTAL END OF THE WIRE REMAINS IN THE POSTERIOR TIBIAL ARTERY AT THE ANKLE. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAS NOT EXPERIENCED 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. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. TWO POSSIBLE LOTS WERE IDENTIFIED DURING A SEARCH OF GLOBAL SALES DATA. ONE RELEVANT NON-CONFORMANCE WAS FOUND ON ONE WIRE COMPONENT LOT; HOWEVER, ALL NON-CONFORMING PRODUCT WAS SCRAPPED AND THERE ARE 100% INSPECTIONS IN PLACE TO CAPTURE THE NON-CONFORMANCE. THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR EITHER LOT NUMBER. THE PRODUCT IFU CAUTIONS, ¿DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, DHR, AND IFU 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. 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 COMPONENT FAILURE UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES 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 REPORTED, DURING A PROCEDURE INVOLVING RECANALIZATION OF THE POSTERIOR TIBIAL ARTERY, A WIRE INCLUDED IN AN UNSPECIFIED COOK MICROPUNCTURE SET SEPARATED IN THE PATIENT. ACCESS WAS OBTAINED IN THE POSTERIOR TIBIAL ARTERY AT THE ANKLE. THE ACCESS SITE WAS NOT SCARRED. THE WIRE WAS NOT PULLED BACK THROUGH THE ENTRY NEEDLE. THE ACCESS NEEDLE WAS REMOVED AND THE SHEATH WAS INSERTED. AS THE USER ATTEMPTED TO REMOVE THE 0.018-INCH WIRE FROM THE SHEATH, THE WIRE SHEARED. PER THE USER, IT IS POSSIBLE THAT THE WIRE CAUGHT ON THE END OF THE SHEATH PRIOR TO SHEARING. THE SEPARATED DISTAL END OF THE WIRE REMAINS IN THE POSTERIOR TIBIAL ARTERY AT THE ANKLE. THE PROCEDURE WAS NOT COMPLETED. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT HAS NOT EXPERIENCED 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
    698574 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other