BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERFORMER INTRODUCER

    MDR report key: 8252549 · Received January 16, 2019

    Report

    Report Number
    1820334-2019-00110
    Event Type
    Malfunction
    Date Received
    January 16, 2019
    Report Date
    March 12, 2019
    Manufacturer
    COOK INC
    Product Code
    DYB
    UDI-DI
    00827002106789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNKNOWN, UNAVAILABLE, OR UNCHANGED. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, MANUFACTURES INSTRUCTIONS, QUALITY CONTROL, AND TRENDS OF THE RETURNED DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE CUSTOMER ONLY RETURNED A LABEL FOR THE DEVICE. PR 251240 AND PR 251243 ARE SEPARATE COMPLAINTS ON LOT 9159538. BOTH COMPLAINTS ARE ON VALVE LEAKAGE AND BOTH ARE FROM SOUTH JERSEY VASCULAR INSTITUTE. THE CUSTOMER RETURNED TWO DEVICES FOR PR 251240. THESE DEVICES WILL BE USED AS REPRESENTATIVE DEVICES FOR THIS INVESTIGATION, AS PART OF THAT LOT WAS ALSO BUILT USING CHECK FLO ASSEMBLIES FROM THE SAME RAW MATERIAL LOT. THE CUSTOMER RETURNED 2 RYCFW-7.0-35-6-RB-CW DEVICES WITH 2 DILATORS FOR PR 251240. BOTH DILATORS WERE NOT INSERTED INTO THE SHEATHS. THERE IS NO VISIBLE DAMAGE ON THE DILATORS. FOR BOTH DEVICES, THE INTRODUCER TUBING WAS OCCLUDED WITH HEMOSTATS AND WATER WAS INJECTED INTO THE SIDE ARM TO TEST FOR LEAKAGE. THE CONNECTOR CAP WAS DISASSEMBLED FROM THE CHECK FLO BODY TO MEASURE THE CAP-TO-BOTTOM DISTANCE. THE CUSTOMER DID NOT RETURN THE COMPLAINT DEVICE. THE CUSTOMER RETURNED TWO DEVICES FROM LOT 9159538 UNDER PR 251240. THESE DEVICES WILL BE USED AS REPRESENTATIVE DEVICES FOR THIS INVESTIGATION, AS THEY ARE FROM THE SAME LOT AS THIS COMPLAINT. THE VISUAL INSPECTION OF THE RETURNED PACKAGE CONFIRMED THAT TWO RYCFW-7.0-35-6-RB-CW DEVICES WITH 2 DILATORS. BOTH DILATORS WERE NOT INSERTED INTO THE SHEATHS. THERE WAS NO VISIBLE DAMAGE ON THE DILATORS. FOR BOTH DEVICES, THE INTRODUCER TUBING WAS OCCLUDED WITH HEMOSTATS AND WATER WAS INJECTED INTO THE SIDE ARM TO TEST FOR LEAKAGE. THE CONNECTOR CAP WAS DISASSEMBLED FROM THE CHECK FLO BODY TO MEASURE THE CAP-TO-BOTTOM DISTANCE. ON THE FIRST DEVICE, THERE WAS BIO MATTER THROUGHOUT THE DEVICE, BUT NO VISIBLE DAMAGE TO THE INTRODUCER. THERE WAS MILD LEAKAGE AROUND THE DISC. THE CAP-TO-BOTTOM DISTANCE WAS 1.385¿. THERE WAS GLUE ON THE TOP OF THE FITTING, BUT NONE IN THE CAP. AS FOR THE SECOND DEVICE, IT TOO HAD BIOMATTER THROUGHOUT. HOWEVER, THIS DEVICE ALSO HAD A KINK AT 2.9CM FROM THE PROXIMAL FITTING, AND THE TUBING WAS FLATTENED AT 1.8CM FROM THE DISTAL TIP AND CONTINUED TO THE DISTAL TIP. THERE WAS ALSO SIGNIFICANT LEAKAGE AROUND THE DISC. THE CAP-TO-BOTTOM DISTANCE WAS 1.390¿. THERE WAS SIGNIFICANT GLUE ON THE TOP OF THE FITTING AND IN THE REST OF THE CAP. ADDITIONALLY, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED NO NONCONFORMING EVENTS WHICH COULD CONTRIBUTE TO THIS FAILURE MODE. IT SHOULD BE NOTED THAT THE ONLY OTHER COMPLAINTS FOR THIS LOT NUMBER ARE ALL FROM THE SAME FACILITY. FURTHERMORE, A REVIEW OF THE MANUFACTURES INSTRUCTIONS AND QUALITY CONTROL PROCEDURES WAS CONDUCTED, AND NO GAPS WERE DISCOVERED. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF OUR INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. WE WILL CONTINUE OUR MONITORING OF SIMILAR COMPLAINTS AND HAVE NOTIFIED THE APPROPRIATE PERSONNEL OF THIS EVENT. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. 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.

    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

    PMA/510(K) NUMBER: PRE-AMENDMENT. 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

    IT WAS REPORTED, THE PERFORMER INTRODUCER BEGAN LEAKING FROM THE DIAPHRAGM DURING AN FISTULA THROMBECTOMY PROCEDURE OF THE PATIENT'S ARM. DATE OF EVENT IS UNKNOWN. ANOTHER MANUFACTURER'S DEVICE WAS USED TO COMPLETE THE PROCEDURE. 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
    47541 PERFORMER INTRODUCER DYB INTRODUCER, CATHETER DYB COOK INC G10678 9159533 00827002106789

    Patients

    Seq Age Sex Outcome Treatment
    1