BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER RX7MM4CM155

    MDR report key: 7885954 · Received September 18, 2018

    Report

    Report Number
    9616099-2018-02397
    Event Type
    Malfunction
    Date Received
    September 18, 2018
    Date of Event
    May 31, 2018
    Report Date
    October 4, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    A 7X40MM 155CM SABER RX PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT FOUR (4) ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY. THE LESION WAS THE ILIAC ARTERY. A GUIDEWIRE CROSSED THE LESION AND THE SABER PTA WAS DELIVERED TO THE LESION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17337641 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 BURST COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (ALTHOUGH NOT PROVIDED) AND PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT SINCE CALCIFIED/RESISTANT LESIONS CAN CAUSE DAMAGE TO A BALLOON. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿THE RATED BURST PRESSURE IS BASED ON THE RESULT OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE LEVEL) WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER PRESSURIZATION. PRIOR TO ANGIOPLASTY, THE CATHETER SHOULD BE EXAMINED TO VERIFY FUNCTIONALITY AND ENSURE THAT ITS SIZE AND SHAPE ARE SUITABLE FOR THE SPECIFIC PROCEDURE FOR WHICH IT IS TO BE USED.¿ NEITHER THE DHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(4). (B)(6).THE DEVICE WAS RETURNED BUT THE ENGINEERING REPORT IS PENDING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THESE LOTS OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. PLEASE NOTE THAT THE SABER DEVICE IN THIS REPORT IS NOT SOLD IN THE US BUT IS SIMILAR TO OTHER CORDIS PTA CATHETERS THAT ARE SOLD IN THE US.

    Description of Event or Problem · 1

    A 7MM4CM155 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED AT 4 ATMOSPHERES (ATM) DURING ITS INITIAL INFLATION. THERE WAS NO PATIENT INJURY AND THE DEVICE WILL BE RETURNED FOR ANALYSIS. THE LESION WAS THE ILIAC ARTERY. A GUIDEWIRE CROSSED THE LESION AND THE SABER PTA WAS DELIVERED TO THE LESION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725234 SABER RX7MM4CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CASHEL N/A 17337641

    Patients

    Seq Age Sex Outcome Treatment
    1