BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRONTO V4 5.5F

    MDR report key: 17297224 · Received July 11, 2023

    Report

    Report Number
    2134812-2023-00032
    Event Type
    Injury
    Date Received
    July 11, 2023
    Date of Event
    June 15, 2023
    Report Date
    June 29, 2023
    Manufacturer
    VASCULAR SOLUTIONS LLC
    Product Code
    QEZ
    UDI-DI
    10841156108977
    PMA / PMN Number
    K072810
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THERE WAS NO PRODUCT RETURNED FOR THIS COMPLAINT. NO RETURNED PRODUCT EVALUATION COULD BE COMPLETED. THE TOP-LEVEL ASSEMBLY TRAVELER WAS REVIEWED. THERE ARE NO DDA'S, NCE'S OR ANY OTHER NONCONFORMANCES RELATED TO THIS LOT THEREFORE SUPPORTING THE DEVICE MET MATERIAL, ASSEMBLY , AND PERFORMANCE SPECIFICATIONS. CASE DETAILS WERE REVIEWED. CUSTOMER STATED "LEFT FEMORAL ANGIOGRAM WAS PERFORMED ON A FRAGILE 91-YEAR-OLD THAT WEIGHED 110LBS. THE PHYSICIAN REPORTED THAT THERE WAS NO HARM FROM THE DEVICE. HE WAS UNABLE TO ADVANCE THE PRONTO V4 CATHETER INTO THE VESSEL." NO UNIT WAS RETURNED TO VSI/TELEFLEX FOR EVALUATION. IT IS UNKNOWN IF ANY DAMAGES WERE PRESENT ON THE UNIT. ADDITIONAL INFORMATION WAS REQUESTED. A RESPONSE WAS RECEIVED. THERE WAS NO REPORT OF ANY VISUAL DEFECTS OF THE PRONTO V4 CATHETER. THERE WAS NO HARM FROM THE DEVICE. PHYSICIAN WAS UNABLE TO ADVANCE VIA THE VESSELS. VESSEL FACTORS SUCH AS CALCIFICATION AND TORTUOSITY ARE UNKNOWN. NO ANGIOGRAMS WERE PROVIDED. A BYPASS WAS ATTEMPTED ON THE PATIENT TO THE PERONEAL ARTERY WHICH WAS UNSUCCESSFUL. A MANUFACTURING RECORD REVIEW WAS COMPLETED AND NO RELATED NONCONFORMANCES WERE FOUND. IT IS UNKNOWN WHAT COULD HAVE CAUSED THE ADVANCEMENT ISSUE OF THE PRONTO. BASED ON THE LIMITED INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE ISSUE IS UNDETERMINABLE.

    Additional Manufacturer Narrative · 0

    (B)(4). AN INVESTIGATION HAS BEEN OPENED TO REVIEW HISTORICAL DATA AND RISK DOCUMENTATION. A FOLLOW UP REPORT WILL BE SUBMITTED AFTER INVESTIGATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRONTO CATHETER WOULD NOT ADVANCE INTO THE VESSEL. ADDITIONAL INFORMATION: DURING AN ANGIOGRAM THROUGH THE LEFT FEMORAL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE PRONTO INTO THE PATIENTS VESSEL THE PHYSICIAN CONFIRMED THAT THERE WAS NO HARM OR INJURY TO THE PATIENT FROM THE DEVICE. THERE WAS NO REPORTED DEFECTS OR KINKS TO THE CATHETER. THE PATIENT WAS TRANSFERRED TO HOSPITAL TO PERFORM A BYPASS TO THE PERONEAL ARTERY BUT FAILED. THEY ARE REPORTED TO STILL BE IN HOSPITAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRONTO CATHETER WOULD NOT ADVANCE INTO THE VESSEL. ADDITIONAL INFORMATION: DURING AN ANGIOGRAM THROUGH THE LEFT FEMORAL. THE PHYSICIAN WAS UNABLE TO ADVANCE THE PRONTO INTO THE PATIENTS VESSEL THE PHYSICIAN CONFIRMED THAT THERE WAS NO HARM OR INJURY TO THE PATIENT FROM THE DEVICE. THERE WAS NO REPORTED DEFECTS OR KINKS TO THE CATHETER. THE PATIENT WAS TRANSFERRED TO HOSPITAL TO PERFORM A BYPASS TO THE PERONEAL ARTERY BUT FAILED. THEY ARE REPORTED TO STILL BE IN HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2194509 PRONTO V4 5.5F CATHETER QEZ VASCULAR SOLUTIONS LLC 4005 723559 10841156108977

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Female NOT REPORTED| NOT REPORTED