BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

    MDR report key: 19239909 · Received May 3, 2024

    Report

    Report Number
    1820334-2024-00611
    Event Type
    Malfunction
    Date Received
    May 3, 2024
    Date of Event
    April 7, 2024
    Report Date
    August 6, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002034600
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN OR UNAVAILABLE. D - SUSPECT MEDICAL DEVICE: THE CUSTOMER PROVIDED COOK WITH A LOT NUMBER AND PRODUCT IDENTIFIER THAT DID NOT MATCH. THIS REPORT CONTAINS PRODUCT INFORMATION THAT CORRESPONDS TO THE REPORTED LOT NUMBER. THE OTHER PRODUCT IDENTIFIER PROVIDED IS G01909-C-PMS-400-FA. CLARIFICATION REGARDING PRODUCT IDENTITY HAS BEEN REQUESTED. G4 ¿ PMA/510(K) #: K171764. 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 OR THAT A DEATH OR SERIOUS INJURY OCCURRED; NOR IS IT ADMISSION 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

    INVESTIGATION ¿ EVALUATION: THE CUSTOMER REPORTED ON 08APR2024 THAT THE WIRE GUIDE BROKE DURING USE ON 07APR2024. NO HARM TO THE PATIENT HAS CURRENTLY BEEN REPORTED. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD AND QUALITY CONTROL PROCEDURES OF THE DEVICE, WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED FOR EVALUATION; THEREFORE, A PHYSICAL EXAMINATION COULD NOT BE CONDUCTED. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE MASTER RECORD (DMR) CONCLUDED THAT SUFFICIENT CONTROLS ARE IN PLACE TO DETECT THIS FAILURE MODE PRIOR TO RELEASE. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) FOR THE DEVICE FOUND RELEVANT RECORDED NONCONFORMANCES THAT COULD HAVE CONTRIBUTED TO THE REPORTED FAILURE MODE. ALL NONCONFORMING DEVICES WERE SCRAPPED PRIOR TO FURTHER PROCESSING. IT SHOULD BE NOTED THAT THERE WERE NO OTHER COMPLAINTS ASSOCIATED WITH THE FINAL PRODUCT LOT NUMBER. COOK WAS UNABLE TO REVIEW PRODUCT LABELING, AS THIS LOT IS NOT SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET. WITH EVIDENCE GATHERED UPON REVIEW OF DMR, DHR AND NO PRODUCT RETURN, COOK WAS NOT ABLE TO FIND EVIDENCE THE DEVICE WAS MANUFACTURED OUT OF SPECIFICATION. COOK WAS NOT ABLE TO FIND EVIDENCE OF NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURN, AND THE RESULTS OF OUR INVESTIGATION, IT WAS CONCLUDED THAT THE CAUSE OF THIS EVENT COULD NOT BE DETERMINED. IT IS NOT KNOWN IF THE WIRE GUIDE WAS MANIPULATED OR WITHDRAWN THROUGH THE NEEDLE, AS A SHARP EDGE CAN DAMAGE THE DELICATE WIRE GUIDE DEVICE. IT IS POSSIBLE THE PATIENT HAD TORTUOUS ANATOMY WHICH COULD HAVE LED TO THIS EVENT. PER THE RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. 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

    IT WAS REPORTED THAT A COOK WIRE GUIDE BROKE. AT THIS TIME, NO ADVERSE EFFECTS OR ADDITIONAL PROCEDURES FOR THE PATIENT WERE REPORTED DUE TO THIS OCCURRENCE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    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
    1305308 SAFE-T-J AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G01909 15679430 00827002034600

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown