BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER RX7MM2CM155

    MDR report key: 7141737 · Received December 22, 2017

    Report

    Report Number
    9616099-2017-01712
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    December 5, 2017
    Report Date
    January 10, 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 · 1

    MANUFACTURING TELEPHONE AND FAX NUMBERS OF CORDIS CASHEL ARE RESPECTIVELY, (B)(4). (B)(6). THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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. THE DEVICE IN THIS REPORT IS NOT SOLD IN THE US BUT IS SIMILAR IN DESIGN AND FUNCTION TO OTHER CORDIS PTA CATHETERS SOLD IN THE US.

    Additional Manufacturer Narrative · 1

    DURING POST-DILATION OF A STENT THAT DID NOT EXPAND ENOUGH IN A LESION IN THE SUPERFICIAL FEMORAL ARTERY AND THE ILIAC ARTERY, THE BALLOON OF A 6X150MM 155CM SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER RUPTURED. THEN, A 7X20MM 155CM SABER PTA CATHETER WAS DELIVERED TO THE ILIAC ARTERY FOR POST-DILATATION; HOWEVER, IT RUPTURED AS WELL. THE PHYSICIAN ASSUMED THAT THE BALLOONS WERE DAMAGED BY A PROTRUDED CALCIFICATION. IT WAS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, HOWEVER, IT WAS COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO ANOMALIES CONFIRMED DURING PREPARATION. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE PATIENT¿S INFORMATION WAS UNKNOWN. THE DEVICE WAS NOT RETURNED FOR ANALYSIS DUE TO A PATIENT INFECTION. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17438272 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿BALLOON BURST¿ COULD NOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE OF THE BURSTS COULD NOT BE DETERMINED. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, VESSEL CHARACTERISTICS (HEAVILY CALCIFIED LESION WITH PROTRUDING CALCIFICATION) LIKELY CONTRIBUTED TO THE REPORTED EVENT AS CALCIFICATION/RESISTANT LESIONS MAY 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 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.¿ NEITHER THE DHR 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. THIS IS ONE OF TWO DEVICES ASSOCIATED WITH THE REPORTED EVENT AND THE MANUFACTURING REPORT NUMBERS ARE 9616099-2017-01707.

    Description of Event or Problem · 1

    DURING POST-DILATION, A 6MM15CM155 SABER PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER OF A STENT THAT DID NOT EXPAND ENOUGH IN A LESION IN THE SUPERFICIAL FEMORAL ARTERY AND THE ILIAC ARTERY, THE BALLOON RUPTURED. THEN ANOTHER SABER PTA ( 7MM2CM155) WAS DELIVERED TO THE ILIAC ARTERY. HOWEVER, IT RUPTURED. THE PHYSICIAN ASSUMED THAT THE BALLOONS WERE DAMAGED BY A PROTRUDED CALCIFICATION. IT WAS UNKNOWN HOW THE PROCEDURE COMPLETED. THE PROCEDURE COMPLETED SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCTS WERE CLINICALLY USED. AND THEY WILL NOT BE RETURNED FOR ANALYSIS DUE TO INFECTION. THERE WERE NO ANOMALIES CONFIRMED DURING PREPARATION. THE PATIENT¿S VESSEL LEVEL OF TORTUOUSNESS WAS UNKNOWN. THE LESION WAS HEAVILY CALCIFIED. THE RATE OF STENOSIS WAS UNKNOWN. THE PATIENT¿S INFORMATION WAS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    922541 SABER RX7MM2CM155 PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER LIT CORDIS CASHEL N/A 17438272

    Patients

    Seq Age Sex Outcome Treatment
    1