BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DYB INTRODUCER, CATHETER

    MDR report key: 20139736 · Received September 4, 2024

    Report

    Report Number
    1820334-2024-01163
    Event Type
    Malfunction
    Date Received
    September 4, 2024
    Report Date
    September 24, 2024
    Manufacturer
    COOK INC
    Product Code
    DYB
    PMA / PMN Number
    K171275
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    D4: BASED ON THE DESCRIPTION OF THE DEVICE, POSSIBLE MODEL NUMBERS AND RPNS ARE G49471 MPIS-5017-18-20.0-LEH; G49472 MPIS-5017-18-30.0-LEH; G49473 MPIS-5017-18-45.0-LEH; AND G49474 MPIS-5017-18-60.0-LEH. E3: OCCUPATION: LEAD TECH. 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

    CORRECTED INFORMATION: B3 = PER THE REPORTER, THE EVENT OCCURRED APPROXIMATELY A MONTH BEFORE 07AUG2024. D4 = A GLOBAL SALES SEARCH CONDUCTED DURING THE INVESTIGATION DETERMINED THE RPN MOST LIKELY TO BE EITHER MPIS-402-10.0-SC-NT-U-SST (GPN G35550) OR MPIS-502-10.0-SC-NT-U-SST (GPN G35551). SUMMARY OF EVENT: AS REPORTED, DURING AN UNKNOWN PROCEDURE INVOLVING A PACEMAKER, AN UNSPECIFIED PALLADIUM-TIPPED MICROPUNCTURE ACCESS SET'S GUIDEWIRE FRAYED WHILE INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO ¿RE-WET¿ THE GUIDEWIRE; HOWEVER, IT PULLED APART. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. ¿NOTHING¿ DETACHED INSIDE THE PATIENT AND THE PATIENT DID "WELL" DURING THE PROCEDURE. 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. ADDITIONAL INFORMATION WAS RECEIVED ON 03SEP2024 STATING THERE WAS RESISTANCE FELT DURING INSERTION OF THE DEVICE. BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE WIRE GUIDE NEVER WENT THROUGH THE NEEDLE. THE WIRE WAS "CLEANED OFF FOR VENOUS ACCESS" IN ATTEMPT TO REWET THE WIRE. ULTRASOUND GUIDANCE WAS NOT USED TO OBTAIN ACCESS THROUGH THE NORMAL LEFT SUBCLAVIAN ARTERY. INVESTIGATION EVALUATION: REVIEWS OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED TO COOK FOR INVESTIGATION. COOK COULD NOT COMPLETE A REVIEW OF THE DEVICE HISTORY RECORD (DHR) DUE TO THE LACK OF A LOT NUMBER FROM THE USER FACILITY. A GLOBAL SHIPMENT SEARCH ON THE USER FACILITY AND COMPLAINT DEVICE WAS PERFORMED BUT COULD NOT DEFINITIVELY DETERMINE THE LOT NUMBER OF THE COMPLAINT DEVICE. AT THIS TIME, COOK COULD NOT CONCLUDE THAT NONCONFORMING PRODUCT FROM THE AFFECTED LOT EXISTS IN HOUSE OR IN THE FIELD. COOK ALSO REVIEWED PRODUCT LABELING. THE PRODUCT IFU PROVIDES NO RELEVANT INFORMATION TO THE USER RELATED TO THE REPORTED FAILURE MODE. A GLOBAL SALES SEARCH FOR THIS CUSTOMER DETERMINED THAT THE RPNS MPIS-402-10.0-SC-NT-U-SST AND MPIS-502-10.0-SC-NT-U-SST WERE MOST LIKELY TO HAVE BEEN USED IN THIS COMPLAINT. A REVIEW OF THE DEVICE MASTER RECORD (DMR) FOR THESE RPNS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. THE INFORMATION PROVIDED UPON REVIEW OF THE DMR, IFU, 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 THAT COMPONENT FAILURE, UNRELATED TO MANUFACTURING OR DESIGN DEFICIENCIES, CONTRIBUTED TO THIS INCIDENT. THE EXACT CONDITIONS EXPERIENCED DURING THE EVENT CANNOT BE DUPLICATED. 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 AN UNKNOWN PROCEDURE INVOLVING A PACEMAKER, AN UNSPECIFIED PALLADIUM-TIPPED MICROPUNCTURE ACCESS SET'S GUIDEWIRE FRAYED WHILE INSIDE THE PATIENT. AN ATTEMPT WAS MADE TO ¿RE-WET¿ THE GUIDEWIRE; HOWEVER, IT PULLED APART. THE GUIDEWIRE WAS REMOVED AND REPLACED WITH ANOTHER SAME TYPE DEVICE TO COMPLETE THE PROCEDURE. ¿NOTHING¿ DETACHED INSIDE THE PATIENT AND THE PATIENT DID "WELL" DURING THE PROCEDURE. 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 03SEP2024 STATING THERE WAS RESISTANCE FELT DURING INSERTION OF THE DEVICE. BLOOD RETURN WAS NOTED UPON INSERTION OF THE ACCESS NEEDLE PRIOR TO ADVANCEMENT OF THE WIRE GUIDE. THE WIRE GUIDE NEVER WENT THROUGH THE NEEDLE. THE WIRE WAS "CLEANED OFF FOR VENOUS ACCESS" IN ATTEMPT TO REWET THE WIRE. ULTRASOUND GUIDANCE WAS NOT USED TO OBTAIN ACCESS THROUGH THE NORMAL LEFT SUBCLAVIAN ARTERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1369257 DYB INTRODUCER, CATHETER DYB COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male