BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER 2MM20CM 150

    MDR report key: 7504712 · Received May 10, 2018

    Report

    Report Number
    9616099-2018-02123
    Event Type
    Malfunction
    Date Received
    May 10, 2018
    Date of Event
    January 1, 2017
    Report Date
    May 10, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    LIT
    UDI-DI
    20705032069219
    PMA / PMN Number
    K971010
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION TO INCLUDE FROM FACILITY NAME:(B)(6). DURING INFLATION OF THE SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE BY THE LOCAL QUALITY REGULATORY AFFAIRS (QRA) TO GET FURTHER INFORMATION UNSUCCESSFULLY (I.E. THE EVENT DATE OF EACH COMPLAINT). NO OTHER INFORMATION WAS PROVIDED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD (DHR) COULD NOT BE CONDUCTED AS A LOT NUMBER WAS NOT PROVIDED. 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 AS CALCIFIED/RESISTANT LESIONS CAN DAMAGE A BALLOON. ACCORDING TO THE INSTRUCTIONS FOR USE, WHICH IS NOT INTENDED AS A MITIGATION, ¿THE RATED BURST PRESSURE IS BASED ON THE RESULTS OF IN VITRO TESTING. AT LEAST 99.9% OF THE BALLOONS (WITH A 95% CONFIDENCE) WILL NOT BURST AT OR BELOW THEIR RATED BURST PRESSURE. USE OF A PRESSURE MONITORING DEVICE IS RECOMMENDED TO PREVENT OVER-PRESSURIZATION. DO NOT EXCEED THE RATED BURST PRESSURE RECOMMENDED ON THE LABEL. 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.¿ WITHOUT A LOT NUMBER TO CONDUCT A DHR REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    DURING INFLATION OF THE SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE BY THE LOCAL QRA TO GET FURTHER INFORMATION UNSUCCESSFULLY (I.E. THE EVENT DATE OF EACH COMPLAINT). NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346713 SABER 2MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS CASHEL 48002020X UNK 20705032069219

    Patients

    Seq Age Sex Outcome Treatment
    1