BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WAVELINQ 4FR

    MDR report key: 14573078 · Received June 2, 2022

    Report

    Report Number
    9616666-2022-00125
    Event Type
    Injury
    Date Received
    June 2, 2022
    Date of Event
    October 1, 2021
    Report Date
    July 12, 2022
    Manufacturer
    CLEARSTREAM TECHNOLOGIES LTD.
    Product Code
    PQK
    UDI-DI
    00801741182754
    PMA / PMN Number
    K182796
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    TODD BERLAND, JASON CLEMENT, NICHOLAS INSTON, PAUL KREIENBERG AND KENNETH OURIEL (2021). PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM. JOURNAL OF VASCULAR SURGERY, 75(3):1038-1046.E3. DOI: 10.1016/J.JVS.2021.09.025 AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE PERFORMED. THE SAMPLE WAS NOT RETURNED TO THE MANUFACTURER FOR INSPECTION/EVALUATION. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE. BASED UPON THE AVAILABLE INFORMATION, THE DEFINITIVE ROOT CAUSE FOR THIS EVENT IS UNKNOWN. THE INSTRUCTIONS FOR USE (IFU) IS ADEQUATE FOR THE REPORTED DEVICE/PATIENT CODE(S) AND PROVIDES GENERAL INSTRUCTIONS FOR USE, AS WELL AS WARNINGS, PRECAUTIONS AND POTENTIAL COMPLICATIONS ASSOCIATED WITH THE DEVICE. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. DEVICE NOT RETURNED

    Additional Manufacturer Narrative · 0

    H10: MANUFACTURING REVIEW: A MANUFACTURING REVIEW WAS NOT REQUESTED AS THE LOT NUMBER REPORTED IS UNKNOWN. INVESTIGATION SUMMARY: THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE RESULT OF THE INVESTIGATION IS CONFIRMED FOR THE PATIENT REPORTS OF ADVERSE EFFECTS OF CARDIAC COMPLICATIONS POST ARTERIOVENOUS FISTULA CREATION. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. LABELING REVIEW: THE INSTRUCTIONS FOR USE OR THE WAVELINQ ENDOAVF SYSTEM WAS REVIEWED AND CONTAINS THE FOLLOWING INFORMATION RELEVANT TO THE REPORTED EVENT: INDICATIONS: THE WAVELINQ¿ ENDOAVF SYSTEM IS INDICATED FOR THE CREATION OF AN ARTERIOVENOUS FISTULA (AVF) USING CONCOMITANT ULNAR ARTERY AND ULNAR VEIN OR CONCOMITANT RADIAL ARTERY AND RADIAL VEIN IN PATIENTS WITH MINIMUM ARTERY AND VEIN DIAMETERS OF 2.0 MM AT THE FISTULA CREATION SITE WHO HAVE CHRONIC KIDNEY DISEASE AND NEED HEMODIALYSIS. 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. PRECAUTIONS: 8. PRIOR TO THE PROCEDURE, ENSURE THAT THE ACCESS LOCATION, ACCESS VESSELS, AND TARGET AVF LOCATION ARE OF APPROPRIATE SIZE TO ACCOUNT FOR THE DEVICES DURING USE. OVERSIZING THE DEVICE TO THE ACCESS VESSEL MAY INCREASE RISK OF VESSEL INJURY, WHICH MAY RESULT IN STENOSIS AND/OR OCCLUSION. VESSEL INJURY MAY IMPACT FUTURE DIALYSIS ACCESS OPTIONS AND/OR THE ABILITY TO PERFORM FUTURE ENDOVASCULAR PROCEDURES FROM THE TARGET ACCESS VESSELS. USERS SHOULD CONSIDER THE POTENTIAL RISK OF DISTAL ARTERIAL STENOSIS AND/OR OCCLUSION ON END STAGE RENAL DISEASE PATIENTS WHEN SELECTING VASCULAR ACCESS SITES FOR THE PROCEDURE. 9. ADJUNCTIVE PROCEDURES ARE EXPECTED TO BE REQUIRED AT THE TIME OF THE INDEX PROCEDURE TO INCREASE AND DIRECT BLOOD FLOW INTO THE AVF TARGET OUTFLOW VEIN TO ASSIST MATURATION. CARE SHOULD BE TAKEN TO PROACTIVELY PLAN FOR ANY ADJUNCTIVE PROCEDURES, SUCH AS EMBOLIZATION COIL PLACEMENT, WHEN USING THE DEVICE. WARNINGS: 3. THE WAVELINQ¿ 4F ENDOAVF SYSTEM SHOULD NOT BE USED IN PATIENTS WHO HAVE KNOWN CENTRAL VENOUS STENOSIS OR UPPER EXTREMITY VENOUS OCCLUSION ON THE SAME SIDE AS THE PLANNED AVF CREATION. 4. THE WAVELINQ¿ 4F ENDOAVF SYSTEM SHOULD NOT BE USED IN PATIENTS WHO HAVE A KNOWN ALLERGY OR REACTION TO ANY DRUGS/ FLUIDS USED IN THIS PROCEDURE. 5. THE WAVELINQ¿ 4F ENDOAVF SYSTEM SHOULD NOT BE USED IN PATIENTS WHO HAVE KNOWN ADVERSE REACTIONS TO MODERATE SEDATION AND/OR ANESTHESIA. 7. DO NOT USE THE DEVICE TO CREATE AN ENDOAVF USING ARTERIAL ACCESS VIA THE RADIAL OR ULNAR ARTERY. THE ENDOAVF SHOULD ONLY BE CREATED USING BRACHIAL ARTERY ACCESS. 17. THE PUNCTURE SITE SHOULD BE CLOSED AND HEMOSTASIS SHOULD BE ACHIEVED BY MANUAL COMPRESSION PER THE INSTRUCTIONS BELOW. USE OF CLOSURE DEVICES WITH THE WAVELINQ¿ 4F ENDOAVF SYSTEM MAY BE ASSOCIATED WITH AN INCREASED RISK OF ACCESS SITE COMPLICATIONS. 18. THE WAVELINQ¿ ENDOAVF SYSTEM HAS ONLY BEEN EVALUATED FOR THE CREATION OF AN AVF BETWEEN THE ULNAR ARTERY AND CONCOMITANT ULNAR VEIN AND BETWEEN THE RADIAL ARTERY AND CONCOMITANT RADIAL VEIN IN THE CLINICAL STUDIES DESCRIBED BELOW. POTENTIAL ADVERSE EVENTS: THE KNOWN POTENTIAL RISKS RELATED TO THE WAVELINQ¿ 4F ENDOAVF SYSTEM AND PROCEDURE, A STANDARD AVF, AND ENDOVASCULAR PROCEDURES MAY INCLUDE, BUT ARE NOT LIMITED TO: ABORTED OR LONGER PROCEDURE; ADDITIONAL PROCEDURES; BLEEDING, HEMATOMA OR HEMORRHAGE; BRUISING; BURNS; DEATH; ELECTROCUTION; EMBOLISM; FAILURE TO MATURE; FEVER; INCREASED RISK OF CONGESTIVE HEART FAILURE; INFECTION; NUMBNESS, TINGLING, AND/OR COOLNESS; OCCLUSION/STENOSIS; PROBLEM DUE TO SEDATION OR ANESTHESIA; PSEUDOANEURYSM; SEPSIS; STEAL SYNDROME OR ISCHEMIA; SWELLING, IRRITATION, OR PAIN; THROMBOSIS; TOXIC OR ALLERGIC REACTION; VENOUS HYPERTENSION (ARM SWELLING); VESSEL, NERVE, OR AVF DAMAGE OR RUPTURE; WOUND PROBLEM. TODD BERLAND, JASON CLEMENT, NICHOLAS INSTON, PAUL KREIENBERG AND KENNETH OURIEL (2021). PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM. JOURNAL OF VASCULAR SURGERY, 75(3):1038-1046.E3. DOI: 10.1016/J.JVS.2021.09.025. 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: DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM', AFTER POST PROCEDURE THERE WERE TWO OCCURRENCES OF CARDIAC COMPLICATIONS. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE IN DIVISION OF VASCULAR SURGERY TITLED 'PERCUTANEOUS ARTERIOVENOUS FISTULA CREATION WITH THE 4F WAVELINQ ENDOAVF SYSTEM', AFTER POST PROCEDURE THERE WERE TWO OCCURRENCES OF CARDIAC COMPLICATIONS. THE RE-INTERVENTION WAS PERFORMED. HOWEVER, THE CURRENT STATUS OF THE PATIENTS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2438513 WAVELINQ 4FR ENDOVASCULAR ARTERIOVENOUS FISTULA DEVICE PQK CLEARSTREAM TECHNOLOGIES LTD. W04200 UNKNOWN 00801741182754

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention