BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 20199493 · Received September 12, 2024

    Report

    Report Number
    1820334-2024-01212
    Event Type
    Malfunction
    Date Received
    September 12, 2024
    Date of Event
    August 30, 2024
    Report Date
    December 5, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K142829
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    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: AS REPORTED, DURING TREATMENT OF PERIPHERAL ARTERIAL DISEASE (PAD), AN UNSPECIFIED COOK 7 FRENCH FLEXOR SHEATH'S HUB SEPARATED UPON REMOVAL. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN TO TARGET THE RIGHT COMMON FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS "NORMAL" AND NOT STENOSED, TORTUOUS, OR CALCIFIED. AT THE BEGINNING OF THE INTERVENTION, THE SHEATH WAS ADVANCED OVER A COOK AMPLATZ WIRE GUIDE WITHOUT RESISTANCE. UPON RETRACTION OF THE SHEATH OVER THE WIRE GUIDE VIA THE HUB TO TREAT AN IPSILATERAL LOCATION, "LITTLE" RESISTANCE WAS FELT, HOWEVER; THE SHEATH HUB SEPARATED. THE DILATOR WAS NOT IN PLACE UPON RETRACTION OF THE SHEATH. THE USER "CLAMPED" DOWN ON THE SHEATH TO PREVENT BLEEDING THROUGH THE SHEATH. THE SHEATH WAS REMOVED BY HAND WITHOUT ANY PROBLEMS OR SIGNIFICANT RESISTANCE. A NEW SHEATH WAS INSERTED WITHOUT ANY PROBLEMS. PER THE REPORTER, THE "INTERVENTION TIME" WAS EXTENDED DUE TO THE DAMAGED SHEATH AND REPLACEMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, 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 HUB WAS SEPARATED WITH THE FLARE INTACT. NO NOTABLE DAMAGE WAS NOTED TO THE SHAFT. THE CUSTOMER DID NOT PROVIDE THE LOT NUMBER FOR THE COMPLAINT DEVICE. COOK REVIEWED THE SALES HISTORY FOR THIS CUSTOMER AND WAS UNABLE TO DETERMINE THE COMPLAINT LOT, THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES, ¿REINSERTION OF DILATOR PRIOR TO REMOVAL OF FLEXOR SHEATH INCREASES THE STRENGTH OF THE SHEATH AND LESSENS THE RISK OF DEVICE SEPARATION. IF RESISTANCE IS ANTICIPATED OR ENCOUNTERED DURING WITHDRAWAL OF FLEXOR SHEATH, CONSIDER CAREFULLY REINSERTING THE DILATOR PRIOR TO CONTINUING REMOVAL.¿ 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, IFU, RETURNED DEVICE, 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, UNRELATED TO THE DESIGN OR MANUFACTURING OF THE COMPLAINT DEVICE, CAUSED THIS INCIDENT. IT IS POSSIBLE THAT THE DEVICE WAS DAMAGED WHEN RESISTANCE WAS FELT WHEN WITHDRAWING THE DEVICE TO REPOSITION IT DURING THE PROCEDURE, BUT THAT ALSO CANNOT DEFINITIVELY BE DETERMINED. 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 TREATMENT OF PERIPHERAL ARTERIAL DISEASE (PAD), AN UNSPECIFIED COOK 7 FRENCH FLEXOR SHEATH'S HUB SEPARATED UPON REMOVAL. CONTRALATERAL ACCESS WAS OBTAINED IN THE LEFT GROIN TO TARGET THE RIGHT COMMON FEMORAL ARTERY. THE ACCESS SITE WAS NOT SCARRED, AND THE ANATOMY WAS "NORMAL" AND NOT STENOSED, TORTUOUS, OR CALCIFIED. AT THE BEGINNING OF THE INTERVENTION, THE SHEATH WAS ADVANCED OVER A COOK AMPLATZ WIRE GUIDE WITHOUT RESISTANCE. UPON RETRACTION OF THE SHEATH OVER THE WIRE GUIDE VIA THE HUB TO TREAT AN IPSILATERAL LOCATION, "LITTLE" RESISTANCE WAS FELT, HOWEVER; THE SHEATH HUB SEPARATED. THE DILATOR WAS NOT IN PLACE UPON RETRACTION OF THE SHEATH. THE USER "CLAMPED" DOWN ON THE SHEATH TO PREVENT BLEEDING THROUGH THE SHEATH. THE SHEATH WAS REMOVED BY HAND WITHOUT ANY PROBLEMS OR SIGNIFICANT RESISTANCE. A NEW SHEATH WAS INSERTED WITHOUT ANY PROBLEMS. PER THE REPORTER, THE "INTERVENTION TIME" WAS EXTENDED DUE TO THE DAMAGED SHEATH AND REPLACEMENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES OR EXPERIENCE ANY ADVERSE EFFECTS DUE TO THE OCCURRENCE.

    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
    1584423 DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown