BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PHOENIX DEFLECT SYSTEM, 2.2MM X 130CM, 6F (KIT)

    MDR report key: 15712719 · Received November 1, 2022

    Report

    Report Number
    3008847191-2022-00001
    Event Type
    Malfunction
    Date Received
    November 1, 2022
    Date of Event
    October 17, 2022
    Report Date
    March 20, 2023
    Manufacturer
    PHILIPS VOLCANO
    Product Code
    MCW
    PMA / PMN Number
    K140944
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BLOCK D10: CORRECTED CONCOMITANT MEDICAL PRODUCTS FROM CORDIS: 0.035" GUIDEWIRE TO PHILIPS: 0.014¿ PHOENIX GUIDEWIRE. BLOCK G3: BASED ON ADDITIONAL INFORMATION RECEIVED ON 27 FEBRUARY 2023, THE CORRECT SIZE GUIDEWIRE WAS USED CONCOMITANTLY WITH THE PHOENIX CATHETER. BLOCK H3: CORRECTED FROM "THE PHOENIX CATHETER WAS RETURNED INTACT TO A NON-PHILIPS .035 GUIDEWIRE" TO "THE PHOENIX CATHETER WAS RETURNED INTACT TO PHILIPS 0.014 PHOENIX GUIDEWIRE". BLOCK H6: THE PROBABLE CAUSE OF THE REPORTED FAILURE IS LIKELY DAMAGE NOT EXPECTED DURING ROUTINE USE. INVESTIGATION CONCLUSIONS CORRECTED FROM "CODE #18- FAILURE TO FOLLOW INSTRUCTIONS" AND "CODE #22- KNOWN INHERENT RISK OF DEVICE" TO "CODE #61- UNINTENDED USE ERROR CAUSED OR CONTRIBUTED TO EVENT". SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    THIS CASE WAS REVIEWED AND INVESTIGATED ACCORDING TO THE MANUFACTURER¿S POLICY. REPORT SOURCE: COUNTRY IS GERMANY. THE PHOENIX CATHETER WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION, THUS NO RETURNED PRODUCT INVESTIGATION WAS PERFORMED. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Additional Manufacturer Narrative · 0

    BLOCKS D1 & D4: CORRECTED BRAND NAME FROM PHOENIX CATHETER SYSTEM, 2.2MM X 130CM, 6F (KIT) TO PHOENIX DEFLECT SYSTEM, 2.2MM X 130CM, 6F (KIT), CORRECTED MODEL # FROM P22130K TO PD22130K. BLOCKS D9/G3: THE PHOENIX CATHETER WAS RETURNED FOR EVALUATION. BLOCK H3: THE PHOENIX CATHETER WAS RETURNED INTACT TO A NON-PHILIPS .035 GUIDEWIRE AND 6F INTRODUCER SHEATH. VISUAL INSPECTION FOUND A DETACHED POLYOLEFIN JACKET AT THE PROXIMAL END, EXPOSING A BROKEN ELBOW WHICH HAS A POTENTIALLY SHARP EDGE. ADDITIONALLY, TWO KINKS WERE OBSERVED ON THE CATHETER SHAFT. AN ATTEMPT WAS MADE TO REMOVE THE CATHETER FROM THE GUIDEWIRE AND INTRODUCER SHEATH BUT WERE UNSUCCESSFUL. THE GUIDEWIRE WAS STUCK, AND THE LINING OF THE CATHETER SHAFT CRUMPLED AND PREVENTED THE DISTAL END OF THE CATHETER TO EXIT THE INTRODUCER SHEATH. BLOCK H6: THE PROBABLE CAUSE OF THE OBSERVED FAILURE IS LIKELY DUE TO THE USE OF AN .035 CORDIS GUIDEWIRE (BASED ON INFORMATION RECEIVED). IN THE IFU, THIS GUIDEWIRE IS NOT LISTED AS A COMPATIBLE GUIDEWIRE FOR THE PHOENIX CATHETER. SUBMISSION OF THIS REPORT DOES NOT, IN ITSELF, REPRESENT A CONCLUSION BY THE MANUFACTURER AND/OR AUTHORIZED REPRESENTATIVE OR THE NATIONAL COMPETENT AUTHORITY THAT THE CONTENT OF THIS REPORT IS COMPLETE OR ACCURATE, THAT THE MEDICAL DEVICE(S) LISTED FAILED IN ANY MANNER AND/OR THAT THE MEDICAL DEVICE(S) CAUSED OR CONTRIBUTED TO AN ALLEGED DEATH OR DETERIORATION IN THE STATE OF THE HEALTH OF ANY PERSON.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PHOENIX CATHETER WAS USED FOR A THERAPEUTIC PERIPHERAL PROCEDURE IN A SEVERELY CALCIFIED PROXIMAL SFA. THE PHOENIX WAS INSERTED IN THE FIRST STENOSIS AND WAS SUCCESSFULLY TREATED WITH THREE PASSES. DURING REMOVAL, RESISTANCE WAS NOTED SHORTLY BEFORE THE SHEATH ENTRANCE AND FLUOROSCOPY CONFIRMED A CATHETER DEFECT. THE DECISION WAS MADE TO REMOVE THE CATHETER, NON-MANUFACTURER SHEATH AND GUIDEWIRE AS A UNIT; WHILE PLACING A SNARE TO ASSIST WITH REMOVAL. HOWEVER, THE CATHETER WAS ABLE TO BE REMOVED WITHOUT HAVING TO USE THE SNARE. MICROSCOPIC INSPECTION OF THE CATHETER FOUND A SHAFT RUPTURE AND AN ELONGATED HELIX (PHOTO EXPOSED A SHARP EDGE). FLUOROSCOPY CONFIRMED NOTHING WAS RETAINED IN THE PATIENT. THE PATIENT IS DOING WELL WITH NO INJURY REPORTED. FURTHER TREATMENT FOR THE REST OF THE STENOSIS IS SCHEDULED AT A LATER DATE. IT IS UNKNOWN IF THE MULTIPLE PROCEDURES WAS PREPLANNED; HOWEVER, INFORMATION OBTAINED CONFIRMS THAT THE PATIENT WAS NOT PLACED AT ADDITIONAL RISK. THIS PRODUCT PROBLEM IS BEING SUBMITTED BECAUSE THE PHOENIX CATHETER SHAFT RUPTURED EXPOSING SHARP EDGES. THERE IS A POTENTIAL FOR HARM IF THE MALFUNCTION WERE TO RECUR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1285160 PHOENIX DEFLECT SYSTEM, 2.2MM X 130CM, 6F (KIT) CATHETER, PERIPHERAL, ATHERECTOMY MCW PHILIPS VOLCANO PD22130K 10152102

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Female CORDIS: 0.035 GUIDEWIRE| PHILIPS: 0.014¿ PHOENIX GUIDEWIRE| TERUMO: 6F INTRODUCER SHEATH