BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE

    MDR report key: 11670493 · Received April 15, 2021

    Report

    Report Number
    1820334-2021-01138
    Event Type
    Malfunction
    Date Received
    April 15, 2021
    Date of Event
    April 1, 2021
    Report Date
    July 7, 2021
    Manufacturer
    COOK INC
    Product Code
    DQX
    UDI-DI
    00827002035621
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNCHANGED, OR UNAVAILABLE. CORRECTED INFORMATION: D2: COMMON NAME & PRODUCT CODE. SUMMARY OF EVENT: AS REPORTED, DURING A CARDIAC CATHETERIZATION INVOLVING ANGIOGRAPHY OF THE PULMONARY ARTERY VIA RIGHT-SIDED VENOUS ACCESS, AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE BROKE WITHIN ANOTHER MANUFACTURER'S PIGTAIL CATHETER. THE WIRE REPORTEDLY DID NOT ADVANCE PROPERLY WITHIN THE CATHETER AND BECAME STUCK AND UNABLE TO REMOVE FROM THE CATHETER. THE WIRE WAS IN PLACE FOR APPROXIMATELY FIVE MINUTES. THE ANATOMY WAS NOT CALCIFIED OR TORTUOUS. STENTS WERE PRESENT IN THE PULMONARY ARTERY. THE WIRE AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NEW PRODUCTS. THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. INVESTIGATION EVALUATION: REVIEWS OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL PROCEDURES WERE CONDUCTED DURING THE INVESTIGATION. A VISUAL INSPECTION OF THE COMPLAINT DEVICE WAS ALSO CONDUCTED. THE THSF-35-260-AES, AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE WAS RETURNED, STUCK WITHIN A COMPETITOR'S 5FR. CATHETER (CORDIS / TEMPO 5). THE INVESTIGATION DISCOVERED THE DISTAL WELD CONNECTION HAD BROKEN AWAY FROM THE INNER SAFETY WIRE. THIS RESULTED IN A SECTION OF THE COIL BECOMING SLIGHTLY ELONGATED AT THE PROXIMAL END, WHERE THE SHAFT OF THE GUIDE AND COMPETITOR¿S HUB WERE LOCATED. THE WELD BALL WAS STILL ATTACHED TO THE COIL WITH NO EVIDENCE OF COIL ELONGATION OR MANDRIL WIRE PROTRUSION AT THE DISTAL TIP OF THE WIRE GUIDE. AN UNSUCCESSFUL ATTEMPT WAS MADE TO REMOVE THE WIRE FROM THE CATHETER. A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED. NO RELATED NON-CONFORMANCES WERE FOUND, AND THERE HAVE BEEN NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BECAUSE THERE IS OBJECTIVE EVIDENCE THAT THE DHR WAS FULLY EXECUTED AND NO OTHER LOT-RELATED COMPLAINTS HAVE BEEN RECEIVED FROM THE FIELD, COOK HAS CONCLUDED THAT THERE IS NO EVIDENCE THAT NON-CONFORMING PRODUCT EXISTS IN HOUSE OR IN THE FIELD. THE INFORMATION PROVIDED UPON REVIEW OF COMPLAINT FILE, DEVICE HISTORY RECORD, COMPLAINT HISTORY, DEVICE MASTER RECORD, AND DESIGN VERIFICATION TESTING PROVIDE OBJECTIVE EVIDENCE TO SUPPORT THAT THE DEVICE WAS MANUFACTURED TO SPECIFICATION. THE PRODUCT IFU WARNS AGAINST FORCEFUL ANGULATION AND CAUTIONS THE USER NOT TO ADVANCE OR WITHDRAW THE WIRE GUIDE IF RESISTANCE IS ENCOUNTERED. THE IFU ALSO INSTRUCTS TO INSPECT THE WIRE FOR KINKS OR DAMAGE PRIOR TO USE. COOK HAS CONCLUDED THAT SUFFICIENT INSPECTION ACTIVITIES ARE IN PLACE TO IDENTIFY THIS FAILURE MODE PRIOR TO DISTRIBUTION. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THAT COMPONENT FAILURE WITHOUT ANY DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THIS INCIDENT. 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

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    COMMON DEVICE NAME & PRODUCT CODE: DQX WIRE, GUIDE, CATHETER. CUSTOMER NAME AND ADDRESS: PHONE: (B)(6). OCCUPATION: PROFESSOR. PMA/510(K) NUMBER: K171764. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    AS REPORTED, DURING A CARDIAC CATHETERIZATION INVOLVING ANGIOGRAPHY OF THE PULMONARY ARTERY VIA RIGHT-SIDED VENOUS ACCESS, AN AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE BROKE WITHIN ANOTHER MANUFACTURER'S PIGTAIL CATHETER. THE WIRE REPORTEDLY DID NOT ADVANCE PROPERLY WITHIN THE CATHETER AND BECAME STUCK AND UNABLE TO REMOVE FROM THE CATHETER. THE WIRE WAS IN PLACE FOR APPROXIMATELY FIVE MINUTES. THE ANATOMY WAS NOT CALCIFIED OR TORTUOUS. STENTS WERE PRESENT IN THE PULMONARY ARTERY. THE WIRE AND CATHETER WERE REMOVED TOGETHER FROM THE PATIENT, AND THE PROCEDURE WAS COMPLETED WITH NEW PRODUCTS. THERE WAS NO HARM TO THE PATIENT. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572135 AMPLATZ EXTRA-STIFF SUPPORT WIRE GUIDE DQX WIRE, GUIDE, CATHETER DQX COOK INC G03562 13646825 00827002035621

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR CORDIS 5.2 FR CATHETER| CORDIS 5.2 FR CATHETER