BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    A4GW6, LATIS DUAL LUMEN, 9MM-60CM

    MDR report key: 9434384 · Received December 6, 2019

    Report

    Report Number
    2027111-2019-00652
    Event Type
    Malfunction
    Date Received
    December 6, 2019
    Date of Event
    September 19, 2019
    Report Date
    January 22, 2020
    Manufacturer
    APPLIED MEDICAL RESOURCES
    Product Code
    DXE
    UDI-DI
    00607915111175
    PMA / PMN Number
    K973465
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE EVENT UNIT WAS RETURNED TO APPLIED MEDICAL FOR EVALUATION. ENGINEERING CONFIRMED THAT THE TIP OF THE CATHETER HAD SEPARATED FROM THE BODY. BASED ON THE CONDITION OF THE RETURNED UNIT, THE REPORTED EVENT WAS CAUSED BY A MATERIAL CHANGE, WHICH MADE THE DEVICE MORE SUSCEPTIBLE TO UV LIGHT. APPLIED MEDICAL CONTINUOUSLY SEEKS TO IMPROVE THE FORM, FUNCTION AND EASE OF USE OF ITS PRODUCTS. AS PART OF THIS PROCESS, APPLIED MEDICAL HAS RECENTLY IMPLEMENTED MATERIAL AND PROCESS ENHANCEMENTS INTENDED TO FURTHER MINIMIZE THE POTENTIAL FOR THIS TYPE OF EVENT TO OCCUR.

    Description of Event or Problem · 0

    PROCEDURE PERFORMED: NA. CER 1 OF 5: 2019-002503 CER 2 OF 5: 2019-002519 CER 3 OF 5: 2019-002520 CER 4 OF 5: 2019-002811 (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED) CER 5 OF 5: 2020-000089 (ADDITIONAL CER CREATED ON 10JAN2020 FOR THE TIP FRACTURE OF THE UNDAMAGED DEVICE). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL SEALED INSIDE ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31OCT2019 FROM QUALITY CONTROL ENG: PLEASE NOTE I HAVE ONLY 3 NON-STERILE AND 3 STERILE UNITS FROM LOT# 1312586. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25NOV2019 FROM APPLIED MEDICAL [ENGINEER], AND THROUGH DISCUSSION ON 26NOV2019 WITH APPLIED MEDICAL [ENGINEER]: 5 NON-STERILE DEVICES WERE RECEIVED FOR INVESTIGATION. 3 DEVICES ALREADY HAD CERS MADE FOR THEM. 1 DEVICE WAS UNDAMAGED AND NO CER IS NEEDED FOR THIS DEVICE. THIS DEVICE WILL BE LOGGED IN THIS COMPLAINT (#2019-002503) AS AN ADDITIONAL RETURNED DEVICE. THE OTHER DEVICE WAS DAMAGED, WITH A MISSING TIP, AND WILL BE LOGGED AS A NEW COMPLAINT UNDER COMPLAINT # (B)(4). PICTURE OF RETURNED DEVICES IS AVAILABLE. ADDITIONAL INFORMATION WAS RECEIVED VIA E-MAIL ON 10JAN2020 FROM [ENGINEER] APPLIED MEDICAL REGARDING THE UNDAMAGED DEVICE THAT HAS BEEN RETURNED: A SEPARATE COMPLAINT WASN¿T CREATED FOR THE UNIT THAT WAS INTACT UPON RETURN. HOWEVER, THE TIP FRACTURED DURING FOLLOW UP TESTING TODAY. PHOTOS ARE PROVIDED. PATIENT STATUS: NO PATIENT INVOLVEMENT. TYPE OF INTERVENTION: NA.

    Additional Manufacturer Narrative · 1

    RA HAS RECEIVED THE INCIDENT DEVICE AND HAS BEEN ASSIGNED TO ENGINEERING FOR EVALUATION. A FOLLOW-UP REPORT WILL BE SENT UPON COMPLETION OF INVESTIGATION.

    Description of Event or Problem · 1

    PROCEDURE PERFORMED: NA. CER 1 OF 4: (B)(4). CER 2 OF 4: (B)(4). CER 3 OF 4: (B)(4). CER 4 OF 4: (B)(4). (ADDITIONAL CER CREATED ON 26NOV2019 TO LOG THE ADDITIONAL DAMAGED DEVICE RECEIVED). THIS MORNING I LOOKED AT FEW OF THESE LATIS CATHETERS (UNOPENED FROM THE SAME COMPLAINT LOT (1312586) THAT WERE ALSO RETURNED FROM THE SAME HOSPITAL. I LOOKED AT 4 OF THEM AND THEY ALL SEEMED TO HAVE THE SAME PROBLEM. IT TOO BRITTLE AND KINKS EASILY. ONE OF THEM BROKE WHEN I ATTEMPTED TO REMOVE IT OUT OF THE PACKAGE. I STILL HAVE FEW UNOPENED UNITS THAT I CAN SEND TO YOUR TEAM IF YOUR ENGINEERING TEAM WANTS TO EVALUATE THEM. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 15OCT2019 FROM QUALITY CONTROL ENG: THE ONLY NEW INFORMATION IS THAT WHEN I TESTED FEW UNOPENED UNITS (FROM THE SAME COMPLAINT LOT#) THAT WERE ALSO RETURNED FROM THE CUSTOMER ON SEPT 19, I REALIZED THEY WERE ALSO BRITTLE. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 17OCT2019 FROM QUALITY CONTROL ENG: I HAVE 7 UNITS FROM LOT#1312586 REF A4GW6 THAT I CAN RETURN. THREE UNITS ARE OPENED UNITS THAT BROKE WHEN REMOVED FROM THE PACKAGE. REMAINING 4 ARE STILL SEALED INSIDE ITS PACKAGING. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 31OCT2019 FROM LEMAITRE QUALITY CONTROL ENG: PLEASE NOTE I HAVE ONLY 3 NON-STERILE AND 3 STERILE UNITS FROM LOT# 1312586. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 25NOV2019 FROM APPLIED MEDICAL [ENGINEER] , AND THROUGH DISCUSSION ON 26NOV2019 WITH JESSICA PIMENTEL, APPLIED MEDICAL. (ENTERED BY RYAN PERERA) 5 NON-STERILE DEVICES WERE RECEIVED FOR INVESTIGATION. THE OTHER DEVICE WAS DAMAGED AND WILL BE LOGGED AS A NEW COMPLAINT UNDER COMPLAINT # 2019-002811. PICTURE OF RETURNED DEVICES IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1224717 A4GW6, LATIS DUAL LUMEN, 9MM-60CM CATHETER, EMBOLECTOMY DXE APPLIED MEDICAL RESOURCES A4GW6 1312586 00607915111175

    Patients

    Seq Age Sex Outcome Treatment
    1