BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GBX CATHETER, IRRIGATION

    MDR report key: 19174184 · Received April 24, 2024

    Report

    Report Number
    1820334-2024-00570
    Event Type
    Malfunction
    Date Received
    April 24, 2024
    Report Date
    August 6, 2024
    Manufacturer
    COOK INC
    Product Code
    GBX
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, 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): 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. 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

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED OR UNAVAILABLE. CORRECTION: H6- ANNEX A. INVESTIGATION ¿ EVALUATION. THE CUSTOMER STATED THAT THE CATHETER KINKS EASILY AND BECOMES INEFFECTIVE. COOK BECAME AWARE OF THIS EVENT ON (B)(6) 2024. NO HARM TO THE PATIENT HAS CURRENTLY BEEN REPORTED. REVIEWS OF THE DOCUMENTATION, INCLUDING THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, QUALITY CONTROL PROCEDURES AND INSTRUCTIONS FOR USE FOR 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) COULD NOT BE COMPLETED, DUE TO THE LACK OF LOT INFORMATION PROVIDED BY THE FACILITY. COOK ALSO REVIEWED PRODUCT LABELING: THIS PRODUCT IS SUPPLIED WITH AN INSTRUCTIONS FOR USE (IFU) PAMPHLET, C_T_PPD_REV6. PRECAUTIONS: A TFE-COATED WIRE GUIDE IS RECOMMENDED FOR A SMOOTHER CATHETER INTRODUCTION. INSTRUCTIONS FOR USE: 7.) REMOVE THE NEEDLE, LEAVING THE WIRE GUIDE IN PLACE, THEN DILATE WITH THE SUPPLIED DILATOR TO FACILITATE CATHETER INTRODUCTION. 8.) INTRODUCE THE CATHETER OVER THE WIRE GUIDE. NOTE: THE WIRE GUIDE SHOULD ALWAYS EXTEND BEYOND THE CATHETER TIP. HOW SUPPLIED: UPON REMOVAL FROM PACKAGE, INSPECT TO ENSURE NO DAMAGE HAS OCCURRED. EVIDENCE GATHERED UPON REVIEW OF DMR, IFU, NO DHR AND NO PRODUCT RETURN, COOK WAS NOT ABLE TO FIND EVIDENCE THE PRODUCT 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 INSERTION SITE WAS DILATED ENOUGH AND CUT LARGE ENOUGH FOR THE CATHETER. 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 AN 8.5FR FUHRMAN CATHETER KINKED "QUITE EASILY" DURING AN UNKNOWN PROCEDURE AND BECAME INEFFECTIVE. ADDITIONAL INFORMATION REGARDING PATIENT OUTCOME AND EVENT DETAILS HAVE BEEN REQUESTED BUT ARE 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
    1075816 GBX CATHETER, IRRIGATION GBX COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown