BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN

    MDR report key: 19840218 · Received July 26, 2024

    Report

    Report Number
    1820334-2024-01010
    Event Type
    Malfunction
    Date Received
    July 26, 2024
    Date of Event
    June 12, 2024
    Report Date
    November 4, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. G4: PMA/510(K) NUMBERS = (POSSIBLE) K182985, K110009, K082536, K171948, K183467, K130766, AND EXEMPT 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. SUMMARY OF EVENT: AS REPORTED BY ANOTHER MANUFACTURER, DURING A PROCEDURE INVOLVING IMPLANTATION OF THE OTHER MANUFACTURER'S PULMONARY ARTERY PRESSURE MONITORING SENSOR, THE HYDROPHILIC COATING SHEARED OFF TWO UNSPECIFIED COOK ROADRUNNER WIRE GUIDES. THE FIRST WIRE REPORTEDLY BECAME STUCK IN THE OTHER MANUFACTURER'S DELIVERY CATHETER AND THE COATING SHEARED OFF. A SECOND WIRE WAS USED; HOWEVER, THE COATING SHEARED OFF. A DIFFERENT UNKNOWN WIRE WAS THEN USED TO SUCCESSFULLY IMPLANT THE SENSOR. REPORTEDLY, THE PROCEDURE LASTED FOR ONE HOUR, WHICH WAS LONGER THAN EXPECTED. THE PATIENT REMAINED STABLE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL INTERVENTIONS DUE TO THE PROCEDURAL DELAY. REPORTEDLY, THERE WAS NO CONCERN THAT FOREIGN MATTER WAS LEFT IN THE PATIENT. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICES WERE NOT RETURNED TO COOK FOR INVESTIGATION. THE LOT NUMBER WAS NOT PROVIDED TO COOK; THEREFORE, THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY COULD NOT BE REVIEWED. THE PRODUCT IFU STATES ¿TO PREVENT POSSIBLE TISSUE DAMAGE, CARE SHOULD BE TAKEN WHEN MANIPULATING A DEVICE OVER A WIRE GUIDE DURING THE DEVICE¿S PLACEMENT AND WITHDRAWAL. IF RESISTANCE IS FELT DURING DEVICE PLACEMENT, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF RESISTANCE CANNOT BE DETERMINED, REMOVE THE WIRE GUIDE AND DEVICE AS A UNIT TO PREVENT POSSIBLE DAMAGE AND/OR COMPLICATIONS.¿ 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 AND IFU SUGGESTS THAT THERE IS EVIDENCE THE DEVICES WERE 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 OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS EVENT. 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 BY ANOTHER MANUFACTURER, DURING A PROCEDURE INVOLVING IMPLANTATION OF THE OTHER MANUFACTURER'S PULMONARY ARTERY PRESSURE MONITORING SENSOR, THE HYDROPHILIC COATING SHEARED OFF TWO UNSPECIFIED COOK ROADRUNNER WIRE GUIDES. THE FIRST WIRE REPORTEDLY BECAME STUCK IN THE OTHER MANUFACTURER'S DELIVERY CATHETER AND THE COATING SHEARED OFF. A SECOND WIRE WAS USED; HOWEVER, THE COATING SHEARED OFF. A DIFFERENT UNKNOWN WIRE WAS THEN USED TO SUCCESSFULLY IMPLANT THE SENSOR. REPORTEDLY, THE PROCEDURE LASTED FOR ONE HOUR, WHICH WAS LONGER THAN EXPECTED. THE PATIENT REMAINED STABLE AND DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL INTERVENTIONS DUE TO THE PROCEDURAL DELAY. REPORTEDLY, THERE WAS NO CONCERN THAT FOREIGN MATTER WAS LEFT IN THE PATIENT.

    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
    922710 UNKNOWN DQX WIRE, GUIDE, CATHETER DQX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown ABBOTT CARDIOMEMS