BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAPPHIRE II PRO CORONARY DILATATION CATHETER

    MDR report key: 8512012 · Received April 13, 2019

    Report

    Report Number
    3003775186-2019-00009
    Event Type
    Malfunction
    Date Received
    April 13, 2019
    Date of Event
    April 13, 2019
    Manufacturer
    ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD.
    Product Code
    LOX
    PMA / PMN Number
    K163114
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT PRODUCT, SAPPHIRE II PRO 2.0 X 15MM BALLOON CATHETER WITH ASSOCIATED KUSABI CATHETER, WERE RETURNED FOR EVALUATION. PER GROSS EXAMINATION: THE BALLOON WAS INFLATED AND DRIED BLOOD AND CRYSTALLIZED CONTRAST MEDIUM COULD BE FOUND IN THE BALLOON AND INFLATION LUMEN. THE DISTAL SUBASSEMBLY OF THE BALLOON CATHETER WAS NO LONGER ATTACHED TO THE CATHETER AND BROKE AT THE RX PORT BONDING SECTION. THE DISTAL SUBASSEMBLY (INNER INTEGRAL WIRE) OF THE ASSOCIATED KUSABI CATHETER WAS SEVERELY DEFORMED AND SHARPLY TWISTED. NO CASE IMAGE CD WAS PROVIDED FOR ANALYSIS. MICROSCOPIC EXAMINATION REVEALED OF THE HE BROKEN EDGE OF THE BALLOON CATHETER APPEARED TO BE ELONGATED AND PART OF THE INNER LUMEN WAS REMAINED FUSED TO THE PROXIMAL OUTER BODY. THIS INDICATED THAT THE DETACHED BALLOON CATHETER WAS NOT DUE TO THE FUSION FAILURE, BUT LIKELY TO BE BROKEN UNDER HIGH TENSION LOAD. APART FROM ABOVE OBSERVED DAMAGE, NO OTHER ANOMALIES WERE FOUND ON THE RETURNED DEVICES. THE RETURNED BALLOON CATHETER AND THE ASSOCIATED DEVICE WERE EXAMINED IN THE FAILURE ANALYSIS LABORATORY. THE ANALYSIS RESULTS ARE: THE BALLOON DISTAL SUBASSEMBLY DETACHED FROM THE PRODUCT WAS NOT DUE TO A MANUFACTURING ASSEMBLING FAILURE. THE BALLOON DISTAL SUBASSEMBLY DETACHED FROM THE PRODUCT WAS NOT DUE TO THE FUSION FAILURE, BASED ON THE STRETCHED MATERIAL AND RETAINED WELDING MATERIAL. THE FAILURE MODE / APPEARANCE IS CONSISTENT WITH A HIGH TENSILE FORCE APPLIED TO THE CATHETER RESULTING IN ELONGATION AND FAILURE OF THE POLYMERIC RX PORT. THE DISTAL SUBASSEMBLY (INNER INTEGRAL WIRE) OF THE ASSOCIATED KUSABI CATHETER WAS SEVERELY DEFORMED AND SHARPLY TWISTED AND THIS FAILURE MODE / APPEARANCE IS CONSISTENT WITH THE DEFORMATION OF ENTANGLEMENT. THERE ARE NO SIGNS OF MANUFACTURING DEFECTS ON THE RETURNED PRODUCTS AND / OR THE LOT INFORMATION FROM THIS PRODUCT. A POSSIBLE SCENARIO FOR THIS EVENT, THAT IS CONSISTENT WITH THE OBSERVATIONS FROM THE INVESTIGATION, IS AS FOLLOWS: IN THIS CASE, THE DEFORMATION AND SEPARATION OF BALLOON DISTAL PART MAY HAVE BEEN CAUSED BY THE BALLOON CATHETER WAS CAUGHT ON ANOTHER CATHETER (KUSABI) WHILE WITHDRAWN THE BALLOON CATHETER WITH AN EXCESSIVE FORCE. WHEN USING TWO BALLOON CATHETERS AT THE SAME TIME IN A PROCEDURE, THERE IS A POSSIBILITY OF HAVING A BALLOON CATHETER TWIST AROUND ANOTHER BALLOON CATHETER. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THERE IS NO EVIDENCE OF A PRODUCT MALFUNCTION, INADEQUACY IN THE IFU, OR A MANUFACTURING DEFECT. THE INSTRUCTIONS FOR USE STATE THE FOLLOWING WARNING "IF RESISTANCE IS MET DURING MANIPULATION, DETERMINE THE CAUSE OF THE RESISTANCE BEFORE PROCEEDING." NO REMEDIAL ACTION IS BEING PERFORMED BY ORBUSNEICH IN RESPONSE TO THIS EVENT AT THIS TIME.

    Description of Event or Problem · 1

    A SAPPHIRE2 PRO 2.0/15 MM WAS INSERTED AND USED AS AN ANCHOR IN 4PD AND A KUSABI WAS USED AS AN ANCHOR IN 4AV COLLATERAL. USING A SASUKE THE CTO LESION AT 4AV WAS CROSSED AND THEN THE SASUKE WAS REMOVED AND A SAPPHIRE2 PRO 1.0/10 MM AND A SAPPHIRE2 PRO 2.0/10 MM WERE CROSSED, INFLATED AND REMOVED IN TURN TO PLACE A STENT. SUBSEQUENTLY THE SAPPHIRE2 PRO 2.0/15 MM PLACED AS AN ANCHOR AT 4PD WAS REMOVED AND DURING THE REMOVAL THE SAPPHIRE2 PRO 2.0/15 MM RESISTANCE WAS MET AND REMOVED WITH FORCE. IT WAS FOUND OUTSIDE THE BODY THE BALLOON BROKE OFF ON THE GW. NOTHING REMAINED IN THE BODY. THE PHYSICIAN COMMENTED THAT THE BREAKAGE OCCURRED INSIDE THE VESSEL OUTSIDE THE GC. THE PROCEDURE CONTINUED AND COMPLETED AS PLANNED. IT WAS DEEMED THE SAPPHIRE2 PRO 2.0/15 MM GOT TANGLED WITH THE KUSABI AND THE BALLOON BROKE OFF. THE PHYSICIAN SUSPECTED THE EVENT OCCURRED BECAUSE TOO MANY DEVICES WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    305123 SAPPHIRE II PRO CORONARY DILATATION CATHETER CORONARY DILATATION CATHETER LOX ORBUSNEICH MEDICAL (SHENZHEN) CO., LTD. 4294461811

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening