BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BENTSON STRAIGHT FIXED CORE WIRE GUIDE

    MDR report key: 19966771 · Received August 12, 2024

    Report

    Report Number
    1820334-2024-01075
    Event Type
    Malfunction
    Date Received
    August 12, 2024
    Date of Event
    July 9, 2024
    Report Date
    September 6, 2024
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002006911
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    E1: CUSTOMER NAME AND ADDRESS = (B)(6). E3: OCCUPATION = INTERVENTIONAL RADIOLOGIST. G4: PMA/510(K) NUMBER = K171764. H3: (OTHER): THE DEVICE HAS BEEN RETURNED AND PRELIMINARY EVALUATION HAS BEEN PERFORMED; HOWEVER, OUR INVESTIGATION IS ONGOING AND DEVICE EVALUATION SUMMARY WILL BE INCLUDED IN OUR FOLLOW UP REPORT ONCE OUR INVESTIGATION HAS BEEN COMPLETED. 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

    SUMMARY OF EVENT: AS ORIGINALLY REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS NOT IN ITS ¿SAFETY NEST¿ PACKAGING. UPON RETURN OF THE COMPLAINT DEVICE ON 31JUL2024, THE GUIDEWIRE WAS ELONGATED/STRETCHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD (DHR), INSTRUCTIONS FOR USE (IFU), SPECIFICATIONS, 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. PHYSICAL EXAMINATION OF THE RETURNED DEVICE FOUND THAT NONE OF THE WIRE GUIDE WAS POKING THROUGH THE PACKAGE. THERE WAS 11.4CM OF WIRE EXTENDING FROM THE HOLDER AND AT APPROXIMATELY 7.5CM FROM THE DISTAL TIP, THE COIL WAS ELONGATED. THE ELONGATION DAMAGE TO THE WIRE GUIDE WAS EXACTLY WHERE THE WIRE SHOULD HAVE BEEN EXTENDING OUT OF THE PROTECTIVE HOLDER, SUGGESTING THAT IT¿S POSSIBLE THE WIRE WAS PINCHED AND PULLED FROM THE HOLDER WHILE IN TRANSIT. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. A REVIEW OF THE DEVICE HISTORY RECORD FOUND NO RELEVANT NON-CONFORMANCES ON THE LOT. A REVIEW OF COMPLAINT HISTORY FOUND NO ADDITIONAL COMPLAINTS FOR THIS LOT NUMBER. THE PRODUCT IFU STATES, "UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED.¿ 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, DHR, 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 HAS CONCLUDED THE CAUSE OF THIS EVENT IS DUE TO THE SHIPPING/HANDLING OF THE DEVICE. FROM THE INFORMATION PROVIDED, NO MANUFACTURING OR DESIGN DEFICIENCIES CAN BE CONFIRMED AT THIS TIME. THE CUSTOMER NOTED THE DEVICE WAS EXTENDED OUT FROM THE HOLDER UPON OPENING THE PACKAGING, AND THE RETURNED DEVICE HAD DAMAGE RIGHT AT THE SPOT WHERE THE WIRE SHOULD HAVE BEEN EXTENDING OUT FROM THE PACKAGE. THE WIRE GUIDE MOST LIKELY BECAME DAMAGED IN TRANSIT, AND IT SHIFTED FURTHER OUT OF THE PACKAGING. 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 ORIGINALLY REPORTED, DURING PREPARATION FOR AN UNKNOWN PROCEDURE, THE BENTSON STRAIGHT FIXED CORE WIRE GUIDE WAS NOT IN ITS ¿SAFETY NEST¿ PACKAGING. UPON RETURN OF THE COMPLAINT DEVICE ON 31JUL2024, THE GUIDEWIRE WAS ELONGATED/STRETCHED. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS 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
    2174550 BENTSON STRAIGHT FIXED CORE WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G00691 16039151 00827002006911

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown G00691-TSFB-35-145