BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABER 2MM20CM 150

    MDR report key: 7494534 · Received May 8, 2018

    Report

    Report Number
    9616099-2018-02121
    Event Type
    Malfunction
    Date Received
    May 8, 2018
    Date of Event
    April 11, 2018
    Report Date
    July 5, 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 · 0

    DURING INFLATION OF A 2X200MM 150CM SABER BALLOON CATHETER, IT WAS REPORTED THAT THE BALLOON RUPTURED AT BELOW THE RATE BURST PRESSURE. ADDITIONAL INFORMATION WAS RECEIVED AND DURING FAL ANALYSIS THAT THE LUER HUB WAS ALSO NOTED TO BE CRACKED. THERE WAS NO PATIENT INJURY. THE DEVICE COULD NO LONGER BE USED AND IT WAS REPLACED WITH ANOTHER DEVICE. SEVERAL ATTEMPTS HAVE BEEN MADE TO GET FURTHER INFORMATION UNSUCCESSFULLY (I.E. THE EVENT DATE OF THE COMPLAINT). NO OTHER INFORMATION WAS PROVIDED. ONE NON-STERILE UNIT OF A SABER 2MM20CM 150 BALLOON CATHETER WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG. PER VISUAL ANALYSIS, THE BALLOON OF THE SABER WAS OBSERVED AS HAD BEEN PREVIOUSLY INFLATED AND DEFLATED. ALSO, DRIED BLOOD RESIDUES COULD BE OBSERVED INSIDE THE BALLOON. BESIDES, A CRACKED CONDITION WAS OBSERVED ON THE HUB OF THE UNIT AS RECEIVED. THE HUB OF THE UNIT WAS REVIEWED UNDER VISION SYSTEM TO INSPECT FOR ANY TOOL MARKS THAT COULD HAVE CAUSED THE CRACK CONDITION. NEITHER TOOL MARKS NOR VISUAL EVIDENCE OF ANY CHEMICAL DEGRADATION OR DAMAGES IN THE MATERIAL WAS NOTED. NO OTHER ANOMALIES FOUND. PER ADDITIONAL MICROSCOPIC ANALYSIS, A THOROUGH REVIEW ON THE BALLOON OF THE UNIT (WITH SPECIAL ATTENTION TO ANY SIGNS OF RUPTURE CONDITIONS THAT COULD LEAD TO A BALLOON BURST EVENT) WAS PERFORMED. HOWEVER, BESIDES DRIED CRYSTALS FROM THE SALINE SOLUTION ALONG WITH THE ALREADY MENTIONED DRIED BLOOD RESIDUES OBSERVED INSIDE THE BALLOON OF THE UNIT, NO PHYSICAL RUPTURE ON THE ACTUAL BALLOON COULD BE OBSERVED. BALLOON LEAK TEST WAS PERFORMED WITH NO SUCCESS. WATER WAS APPLIED TO THE INFLATION LUMEN OF CATHETER USING A LAB SAMPLE SYRINGE, AND THE LIQUID COULD NOT FLOW THROUGH THE INFLATION LUMEN UP TO THE BALLOON DUE TO A LEAKAGE IN THE CRACKED HUB OF THE SABER BALLOON CATHETER. THE UNIT WAS SENT TO SEM ANALYSIS TO DETERMINE THE ROOT CAUSE OF THE HUB CRACK. PER SEM ANALYSIS, IT WAS OBSERVED THAT THE CRACK PASSED THROUGH THE THICKNESS OF THE HUB. A TRANSVERSAL VIEW OF THE FRACTURED SECTION OF THE HUB SHOWED THAT THE FRACTURED SURFACES PRESENTED EVIDENCE OF BRITTLENESS. THESE TYPES OF SURFACES WERE OBSERVED DURING THE ANALYSIS IN MOST OF THE FRACTURED SURFACE OF THE HUB. IT IS WORTH TO BE NOTED THAT, ON THIS BRITTLE CONDITION IT IS UNKNOWN THE TYPE OF STRESS AND THE RATE AT WHICH THE STRESS CAUSING THE BRITTLE DEFORMATION WAS APPLIED TO REACH THE HUB FRACTURE POINT. NO OTHER ISSUES WERE OBSERVED DURING SEM ANALYSIS. A DEVICE HISTORY RECORD (DHR) REVIEW OF LOT 17278253 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 SINCE THE BALLOON LEAK TEST COULD NOT BE SUCCESSFULLY PERFORMED, AND THERE WAS NO PHYSICAL SIGN OF A RUPTURE NOTED. INSTEAD, A LEAKAGE IN THE LUER HUB OF THE SABER BALLOON CATHETER WAS NOTED DUE TO A CRACKED CONDITION FOUND IN THE HUB. HOWEVER, THE CAUSE OF THE STRESS ON THE MATERIAL THAT LED TO THE CRACK FOUND ON THE HUB COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE HUB CRACK FOUND; HOWEVER, HANDLING FACTORS ARE LIKELY. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), 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. DO NOT USE IF PRODUCT DAMAGE IS SUSPECTED OR EVIDENT. PROPER FUNCTIONING OF THE CATHETER DEPENDS ON ITS INTEGRITY. CARE SHOULD BE USED WHEN HANDLING THE CATHETER. FLUSH ALL DEVICES ENTERING THE VASCULAR SYSTEM WITH STERILE HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION. PRIOR TO USE, ENSURE ALL DEVICES HAVE BEEN FLUSHED AND AIR IS REMOVED FROM THE SYSTEM ACCORDING TO STANDARD MEDICAL PRACTICE. FAILURE TO DO SO COULD RESULT IN AIR ENTERING THE VASCULAR SYSTEM.¿ NEITHER THE PRODUCT ANALYSIS NOR THE DHR REVIEW SUGGESTS THAT THE EVENT REPORTED COULD BE RELATED TO THE MANUFACTURING PROCESS. THEREFORE, NO CORRECTIVE/PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE WAS RECEIVED FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED AND DURING FAL ANALYSIS, THE LUER HUB WAS NOTED TO BE CRACKED. THEREFORE, LUER HUB - CRACKED WAS ADDED TO THE MALFUNCTION CODE. THERE WAS NO CHANGE TO THE REPORTABILITY FOR THIS FILE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS RECEIVED FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    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. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338911 SABER 2MM20CM 150 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT CORDIS CASHEL 48002020X 17278253 20705032069219

    Patients

    Seq Age Sex Outcome Treatment
    1