BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER RX4MM20CM155

    MDR report key: 10453495 · Received August 26, 2020

    Report

    Report Number
    9616099-2020-03868
    Event Type
    Malfunction
    Date Received
    August 26, 2020
    Date of Event
    August 3, 2020
    Report Date
    September 2, 2020
    Manufacturer
    CORDIS CORPORATION
    Product Code
    LIT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, A 4MM X 20CM X 155CM SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER CROSSED THE LESION AND WAS INFLATED, HOWEVER, IT RUPTURED AT 4 ATMOSPHERES (ATM). LEAKAGE OF AN UNKNOWN CONTRAST MEDIA WAS CONFIRMED. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY AND WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE ARTERY DUE TO RUPTURE. THE LESION WAS THE ¿SFS¿. THE DEVICE HAS BEEN STORED IN A HYGIENE-MANAGED STORAGE, WAS TAKEN OUT FROM ITS TRAY, AND INSPECTED. NO DAMAGE WAS CONFIRMED AT THE PACKAGE. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE UNKNOWN GUIDEWIRE CROSSED THE STENOSIS PART WHILE AN X-RAY MACHINE CONFIRMED THE CONDITION OF THE STENOSIS. ADDITIONAL INFORMATION COULD NOT BE OBTAINED AS THE SALES REP COULD NOT VISIT THE HOSPITAL DUE TO COVID-19. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 82193110 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON BURST-AT/BELOW RBP¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED DETERMINED. VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS AS CALCIFICATION IS KNOWN TO CAUSE DAMAGE TO BALLOON MATERIAL. ACCORDING TO THE WARNINGS IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND INTEGRITY, AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED. DO NOT USE IF PRODUCT DAMAGE IS SUSPECTED OR EVIDENT. TO REDUCE THE POTENTIAL FOR VESSEL DAMAGE OR THE RISK OF DISLODGEMENT OF PARTICLES IT IS VERY IMPORTANT THAT THE INFLATED DIAMETER OF THE BALLOON SHOULD APPROXIMATE THE DIAMETER OF THE VESSEL JUST PROXIMAL AND DISTAL TO THE LESION. NEITHER THE PHR NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS NOT SOLD IN THE U.S., HOWEVER, IT IS SIMILAR TO OTHER CORDIS PTA BALLOON CATHETERS THAT ARE SOLD IN THE U.S., WITH THE PRO CODE LIT. THE DEVICE IS ALSO NOT AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    A 4MM X 20CM X 155CM SABER RAPID EXCHANGE (RX) PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) BALLOON CATHETER CROSSED THE LESION AND WAS INFLATED, HOWEVER, IT RUPTURED AT 4 ATMOSPHERES (ATM). LEAKAGE OF AN UNKNOWN CONTRAST MEDIA WAS CONFIRMED. THE DEVICE WAS REMOVED FROM THE PATIENT¿S BODY AND WAS REPLACED WITH A NEW BALLOON CATHETER (NON-CORDIS) TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY. THERE WAS NO DAMAGE TO THE ARTERY DUE TO RUPTURE. THE LESION WAS THE ¿SFS¿. THE DEVICE HAS BEEN STORED IN A HYGIENE-MANAGED STORAGE, WAS TAKEN OUT FROM ITS TRAY, AND INSPECTED. NO DAMAGE WAS CONFIRMED AT THE PACKAGE. THE DEVICE WAS PREPPED AS PER THE INSTRUCTION FOR USE (IFU). THE UNKNOWN GUIDEWIRE CROSSED THE STENOSIS PART WHILE AN X-RAY MACHINE CONFIRMED THE CONDITION OF THE STENOSIS. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS AS IT WAS DISCARDED DUE TO INFECTIOUS DISEASE. ADDITIONAL INFORMATION CANNOT BE OBTAINED AS THE SALES REP CANNOT VISIT THE HOSPITAL DUE TO COVID-19.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    919634 SABER RX4MM20CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CORPORATION N/A 82193110

    Patients

    Seq Age Sex Outcome Treatment
    1