BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WAVELINQ 4FR P

    MDR report key: 12907071 · Received December 1, 2021

    Report

    Report Number
    9616666-2021-00215
    Event Type
    Malfunction
    Date Received
    December 1, 2021
    Date of Event
    November 3, 2021
    Report Date
    January 6, 2022
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741189104
    PMA / PMN Number
    K192239
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A COMPLAINT HISTORY REVIEW WAS PERFORMED. THIS IS THE FOURTH COMPLAINT REPORTED FOR THIS LOT NUMBER. THE DEVICE HISTORY RECORDS WERE REVIEWED AND THERE WAS NOTHING FOUND TO INDICATE THERE WAS A MANUFACTURING RELATED CAUSE FOR THIS EVENT. INVESTIGATION SUMMARY: THE SAMPLE WAS RETURNED FOR EVALUATION. A BEND WAS CONFIRMED ON THE RETURNED VENOUS CATHETER DISTAL MAGNET SHAFT SECTION BETWEEN MAGNETS 8 AND 9. THE ELECTRODE WAS ALSO DAMAGED AND FLATTENED. THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE REPORTED MATERIAL DEFORMATION ISSUE. THE ROOT CAUSE FOR THE REPORTED DAMAGED CATHETER ISSUE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION RECEIVED FROM THE FIELD COMMUNICATIONS AND DEVICE EVALUATION. LABELING REVIEW: THE INSTRUCTIONS FOR USE FOR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: WARNINGS 1. THE WAVELINQ¿ ENDOAVF SYSTEM IS ONLY TO BE USED WITH THE APPROVED COMPONENTS SPECIFIED ABOVE. DO NOT ATTEMPT TO SUBSTITUTE NON-APPROVED DEVICES OR USE ANY COMPONENT OF THIS SYSTEM WITH ANY OTHER MEDICAL DEVICE SYSTEM. USE OF THE SYSTEM WITH OTHER COMPONENTS MAY INTERFERE WITH PROPER FUNCTIONING OF THE DEVICE. CAUTIONS 1. ONLY PHYSICIANS TRAINED AND EXPERIENCED IN ENDOVASCULAR TECHNIQUES, WHO HAVE RECEIVED APPROPRIATE TRAINING WITH THE DEVICE, SHOULD USE THE DEVICE. ENDOVASCULAR TECHNIQUE TRAINING AND EXPERIENCE SHOULD INCLUDE ULTRASOUND VESSEL ACCESS IN THE ARM, GUIDEWIRE NAVIGATION, RADIOGRAPHIC IMAGING, PLACEMENT OF VASCULAR EMBOLIZATION DEVICES (INCLUDING EMBOLIZATION COILS), AND ACCESS HEMOSTASIS. 3. DO NOT KINK, PINCH, CUT, BEND, TWIST, OR PULL EXCESSIVELY OR WITH EXCESSIVE FORCE ON ANY PORTION OF THE DEVICES. DAMAGE TO THE CATHETER BODY MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 4. AVOID SHARP BENDS. THIS MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 5. DO NOT PINCH OR GRASP THE CATHETER WITH EXCESSIVE FORCE OR WITH OTHER INSTRUMENTS. THIS MAY CAUSE THE DEVICE TO BECOME INOPERABLE. 6. DO NOT BEND THE RIGID PORTION OF THE CATHETER NEAR THE ELECTRODE OR BACKSTOP. 7. DO NOT TOUCH OR HANDLE THE ACTIVE ELECTRODE. ELECTRODE DISLODGEMENT MAY OCCUR. 8. ALWAYS USE THE HEMOSTASIS VALVE CROSSER TO ASSIST INSERTION OF THE VENOUS CATHETER THROUGH THE INTRODUCER SHEATH. INSERTION INTO INTRODUCER SHEATH WITHOUT HEMOSTASIS VALVE CROSSER MAY DAMAGE ELECTRODE. 9. DO NOT ATTEMPT TO REMOVE THE HEMOSTASIS VALVE CROSSER LOCATED ON THE VENOUS DEVICE. DEVICE DAMAGE OR FRACTURE MAY OCCUR. H10: D4 (EXPIRY DATE: 06/2023), G3, H6 (DEVICE) H11: H6 (METHOD, RESULT, CONCLUSION) H11:SECTION A THROUGH F - THE INFORMATION PROVIDED BY BD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BD. H3 OTHER TEXT : SEE H10.

    Additional Manufacturer Narrative · 0

    AS THE LOT NUMBER FOR THE DEVICE WAS PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORD IS CURRENTLY BEING PERFORMED. THE RETURN OF THE SAMPLE IS PENDING. THE INVESTIGATION OF THE REPORTED EVENT IS CURRENTLY UNDERWAY. (EXPIRY DATE: 06/2023).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR ARTERIOVENOUS FISTULA PROCEDURE, THE CATHETER WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING AN ENDOVASCULAR ARTERIOVENOUS FISTULA PROCEDURE, THE CATHETER WAS ALLEGEDLY DAMAGED. THE PROCEDURE WAS COMPLETED BY USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1807289 WAVELINQ 4FR P ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. WQ4300 CMFU0267 00801741189104

    Patients

    Seq Age Sex Outcome Treatment
    1 Female