BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICROPUNCTURE TRANSITIONLESS ACCESS SET

    MDR report key: 9559030 · Received January 7, 2020

    Report

    Report Number
    1820334-2020-00073
    Event Type
    Malfunction
    Date Received
    January 7, 2020
    Date of Event
    December 26, 2019
    Report Date
    February 25, 2020
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002479401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    B5:CORRECTED INFORMATION: UPON FURTHER REVIEW OF THE FILE, IT WAS DISCOVERED THAT THE TYPE OF PROCEDURE WAS INADVERTENTLY LEFT OUT OF THE DESCRIPTION OF THE EVENT ON THE INITIAL MEDWATCH REPORT. THE PROCEDURE BEING PERFORMED AT THE TIME OF THE EVENT WAS AN ANGIOPLASTY. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. DESCRIPTION OF EVENT. AS REPORTED, WHILE OBTAINING ACCESS FOR AN ARTERIAL ANGIOGRAM WITH FISTULA ACCESS, A MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED IN THE PATIENT' BODY. THE ACCESS SITE WAS NOTED TO BE NORMAL AND NO RESISTANCE WAS REPORTED DURING INSERTION OR REMOVAL. THE DEVICE WAS USED TO FACILITATE THE PLACEMENT OF A LARGER WIRE. NO KINKS WERE NOTED ON THE WIRE, NO ANCILLARY DEVICES WERE USED WITH THE MPIS SET, AND THE WIRE GUIDE WAS NOT MANIPULATED OR REMOVED THROUGH THE ENTRY NEEDLE. ADDITIONAL "STEPS" WERE NECESSARY TO REMOVE THE WIRE; HOWEVER NO INTERVENTIONAL PROCEDURES WERE REQUIRED. NOTHING WAS LEFT INSIDE THE BODY, AND ANOTHER COOK MICROPUNCTURE SET WAS USED TO RE-ACCESS THE PATIENT. 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, DOCUMENTATION, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURER¿S INSTRUCTIONS, AND THE QUALITY CONTROL PROCEDURES OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. THE EVIDENCE INDICATES THE PRODUCT WAS MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWS NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. REVIEWS OF THE MANUFACTURER¿S INSTRUCTIONS, DRAWINGS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED, AND NO GAPS WERE DISCOVERED. ACCORDING TO THE LABELING INCLUDED WITH THE DEVICE, ¿WHEN INSERTING, MANIPULATING OR WITHDRAWING A DEVICE THROUGH AN INTRODUCER, ALWAYS MAINTAIN INTRODUCER POSITION. DO NOT ATTEMPT TO INSERT OR WITHDRAW THE WIRE GUIDE AND/OR INTRODUCER IF RESISTANCE IS FELT.¿ THE DEVICE IS PACKAGED WITH A DRAWING, WARNING TO NOT PULL THE DISTAL SPRING COIL PORTION OF THE WIRE GUIDE THROUGH THE NEEDLE TIP. BASED ON THE INFORMATION PROVIDED AND NO PRODUCT RETURNED, INVESTIGATION HAS CONCLUDED THAT A ROOT CAUSE FOR THIS EVENT COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED ON 29JAN2020 NOTING THAT THE PROCEDURE BEING PERFORMED WAS AN ARTERIAL ANGIOGRAM WITH FISTULA ACCESS. THE ACCESS SITE WAS NOTED TO BE NORMAL AND NO RESISTANCE WAS REPORTED DURING INSERTION OR REMOVAL. THE DEVICE WAS USED TO FACILITATE THE PLACEMENT OF A LARGER WIRE. NO KINKS WERE NOTED ON THE WIRE, NO ANCILLARY DEVICES WERE USED WITH THE MPIS SET, AND THE WIRE GUIDE WAS NOT MANIPULATED OR REMOVED THROUGH THE ENTRY NEEDLE. ADDITIONAL "STEPS" WERE NECESSARY TO REMOVE THE WIRE; HOWEVER NO INTERVENTIONAL PROCEDURES WERE REQUIRED.

    Additional Manufacturer Narrative · 1

    OCCUPATION = UNKNOWN. PMA/510(K) NUMBER = K171275. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, WHILE OBTAINING ACCESS FOR A UNKNOWN PROCEDURE, A MICROPUNCTURE TRANSITIONLESS ACCESS SET UNRAVELED IN THE PATIENT' BODY. NOTHING WAS LEFT INSIDE THE BODY, AND ANOTHER COOK MICROPUNCTURE SET WAS USED TO RE-ACCESS THE PATIENT. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22207 MICROPUNCTURE TRANSITIONLESS ACCESS SET DYB INTRODUCER, CATHETER DYB COOK INC G47940 10108886 00827002479401

    Patients

    Seq Age Sex Outcome Treatment
    1