BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 15672855 · Received October 26, 2022

    Report

    Report Number
    1820334-2022-01657
    Event Type
    Malfunction
    Date Received
    October 26, 2022
    Date of Event
    March 13, 2007
    Report Date
    January 19, 2023
    Manufacturer
    COOK INC
    Product Code
    DTK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE PRODUCT REFERENCE NUMBER IS BELIEVED TO BE ONE OF THE FOLLOWING: (B)(4). PMA/510(K) NUMBER = POSSIBLE 501(K) NUMBERS: K072240, K043509. 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, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: H6 (ANNEXES A & G) SUMMARY OF EVENT: AS REPORTED, DURING A PROCEDURE INVOLVING PLACEMENT OF AN INFERIOR VENA CAVA (IVC) FILTER, AN UNSPECIFIED COOK GUNTHER TULIP FILTER DID NOT FULLY EXPAND. ACCESS WAS OBTAINED IN THE LEFT NECK, USING ULTRASOUND GUIDANCE. A PIGTAIL CATHETER WAS ADVANCED TO THE IVC AND AN INFERIOR VENACAVOGRAM WAS PERFORMED. AN UNKNOWN 8.5 FRENCH SHEATH WAS PLACED, AND AN ATTEMPT WAS MADE TO ADVANCE THE GUNTHER TULIP FILTER. THE UNKNOWN SHEATH WAS NOTED TO BE KINKED AND THE LEGS OF THE FILTER APPEARED TO ¿DIASTASE¿ APPROXIMATELY TWO MILLIMETERS. THE FILTER WAS REMOVED FROM THE SHEATH, AND IT WAS NOTED THAT TWO OF THE FILTER LEGS DID NOT FULLY EXPAND. THE SHEATH WAS THEN REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER SHEATH OVER AN EXCHANGE WIRE. THE UNKNOWN SHEATH WAS NOTED TO HAVE A HOLE IN ITS SIDE AFTER REMOVAL. A NEW GUNTHER TULIP FILTER WAS THEN INSERTED AND DEPLOYED WITHOUT DIFFICULTY. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU) AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. IMAGES WERE NOT PROVIDED. THE LOT NUMBER WAS NOT PROVIDED TO COOK; THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. IT IS UNKNOWN IF THERE WERE RELATED NON-CONFORMANCES OR ADDITIONAL COMPLAINTS ON THE LOT. THE PRODUCT IFU STATES ¿FOR PLACEMENT OF THE FILTER, THE RIGHT JUGULAR VEIN IS PREFERABLE. AN APPROACH VIA THE LEFT JUGULAR VEIN IS POSSIBLE.¿ THE INFORMATION PROVIDED UPON REVIEW OF THE DMR 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 LIMITED INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT A CAUSE FOR THE EVENT COULD NOT BE ESTABLISHED; HOWEVER, PER THE IFU, A RIGHT JUGULAR APPROACH IS PREFERABLE. A LEFT APPROACH WAS USED IN THIS CASE. IT IS UNKNOWN IF THE ACCESS SITE CONTRIBUTED TO THE UNKNOWN SHEATH KINKING, PREVENTING ADVANCEMENT OF THE FILTER. 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 PLACEMENT OF AN INFERIOR VENA CAVA (IVC) FILTER, AN UNSPECIFIED COOK GUNTHER TULIP FILTER DID NOT FULLY EXPAND. ACCESS WAS OBTAINED IN THE LEFT NECK, USING ULTRASOUND GUIDANCE. A PIGTAIL CATHETER WAS ADVANCED TO THE IVC AND AN INFERIOR VENACAVOGRAM WAS PERFORMED. AN UNKNOWN 8.5 FRENCH SHEATH WAS PLACED, AND AN ATTEMPT WAS MADE TO ADVANCE THE GUNTHER TULIP FILTER. THE UNKNOWN SHEATH WAS NOTED TO BE KINKED AND THE LEGS OF THE FILTER APPEARED TO ¿DIASTASE¿ APPROXIMATELY TWO MILLIMETERS. THE FILTER WAS REMOVED FROM THE SHEATH, AND IT WAS NOTED THAT TWO OF THE FILTER LEGS DID NOT FULLY EXPAND. THE SHEATH WAS THEN REMOVED FROM THE PATIENT AND EXCHANGED FOR ANOTHER SHEATH OVER AN EXCHANGE WIRE. THE UNKNOWN SHEATH WAS NOTED TO HAVE A HOLE IN ITS SIDE AFTER REMOVAL. A NEW GUNTHER TULIP FILTER WAS THEN INSERTED AND DEPLOYED WITHOUT DIFFICULTY. THERE HAS BEEN NO REPORT THAT THE PATIENT EXPERIENCED ANY ADVERSE EFFECTS DUE TO THIS EVENT.

    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
    2775110 UNKNOWN DTK FILTER, INTRAVASCULAR, CARDIOVASCULAR DTK COOK INC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male