BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PRODUCT - CORDIS CORPORATION

    MDR report key: 16047898 · Received December 26, 2022

    Report

    Report Number
    9616099-2022-06180
    Event Type
    Injury
    Date Received
    December 26, 2022
    Date of Event
    November 28, 2022
    Report Date
    February 2, 2023
    Manufacturer
    CORDIS US. CORP
    Product Code
    DQX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INFORMATION IS LIMITED DUE TO BEING A SURVEY CASE, ACTUAL EVENT DATE IS UNKNOWN. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT INDICATED ARTERY SPASM STATING: ¿SOMETIMES WHEN WE FORCE THE PENETRATION OF THE GUIDEWIRE THE ARTERY TIGHT AND IS ALMOST IMPOSSIBLE TO RECONDUCT THE CATHETER.¿ ALSO INDICATED VESSEL DISSECTION STATING: ¿BY ERROR, ON ONE OCCASION THE VESSEL WAS CUT BY THE GUIDEWIRE BUT BECAUSE THE INTERACTION OF THE CATHETER WITH THE VESSEL.¿ ALSO INDICATED VESSEL RUPTURE STATING: ¿IT IS SOMETHING RELATIVE USUALLY IF YOU WORK WITH A LITTLE VESSEL OR ATHEROSCLEROTIC VESSEL.¿ ALSO INDICATED VESSEL PERFORATION STATING: ¿SIMILAR SITUATION AS BEFORE¿ ALSO INDICATED MAJOR BLEEDING ¿OUR EXPERIENCE IS ALMOST ALWAYS WHEN THE CATHETER IS USED BY PEOPLE WITHOUT ENOUGH TRAINING. ALMOST ALWAYS IS IN ARTERY VESSELS NEAR OF THORACIC LOCATIONS.¿ THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS AND A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE PERFORMED BECAUSE THE LOT NUMBER FOR THIS PRODUCT IS UNKNOWN. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENTS ¿GUIDEWIRE-TRACKING DIFFICULTY, ARTERIAL SPASM, VASCULAR DISSECTION, VESSEL PERFORATION AND HAEMORRHAGE¿ COULD NOT BE CONFIRMED. THESE ARE ALL WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATIONS OF A PERCUTANEOUS PROCEDURES. USER TECHNIQUE OR PATIENT VESSEL CHARACTERISTICS MAY HAVE CONTRIBUTED TO THE REPORTED EVENTS. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿PROCEDURES REQUIRING PERCUTANEOUS CATHETER/GUIDEWIRE INTRODUCTION SHOULD NOT BE ATTEMPTED BY PHYSICIANS UNFAMILIAR WITH THE POSSIBLE COMPLICATIONS. COMPLICATIONS MAY OCCUR AT ANY TIME DURING OR AFTER THE PROCEDURE. POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO AIR EMBOLISM, HEMATOMA AT THE PUNCTURE SITE, INFECTION, PERFORATION OF THE VESSEL WALL.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT INDICATED ARTERY SPASM STATING: ¿SOMETIMES WHEN WE FORCE THE PENETRATION OF THE GUIDEWIRE THE ARTERY TIGHT AND IS ALMOST IMPOSSIBLE TO RECONDUCT THE CATHETER.¿ ALSO INDICATED VESSEL DISSECTION STATING: ¿BY ERROR, ON ONE OCCASION THE VESSEL WAS CUT BY THE GUIDEWIRE BUT BECAUSE THE INTERACTION OF THE CATHETER WITH THE VESSEL.¿ ALSO INDICATED VESSEL RUPTURE STATING: ¿IT IS SOMETHING RELATIVE USUALLY IF YOU WORK WITH A LITTLE VESSEL OR ATHEROSCLEROTIC VESSEL.¿ ALSO INDICATED VESSEL PERFORATION STATING: ¿SIMILAR SITUATION AS BEFORE¿ ALSO INDICATED MAJOR BLEEDING ¿OUR EXPERIENCE IS ALMOST ALWAYS WHEN THE CATHETER IS USED BY PEOPLE WITHOUT ENOUGH TRAINING. ALMOST ALWAYS IS IN ARTERY VESSELS NEAR OF THORACIC LOCATIONS.¿ THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT INDICATED ARTERY SPASM STATING: ¿SOMETIMES WHEN WE FORCE THE PENETRATION OF THE GUIDEWIRE THE ARTERY TIGHT AND IS ALMOST IMPOSSIBLE TO RECONDUCT THE CATHETER.¿ ALSO INDICATED VESSEL DISSECTION STATING: ¿BY ERROR, ON ONE OCCASION THE VESSEL WAS CUT BY THE GUIDEWIRE BUT BECAUSE THE INTERACTION OF THE CATHETER WITH THE VESSEL.¿ ALSO INDICATED VESSEL RUPTURE STATING: ¿IT IS SOMETHING RELATIVE USUALLY IF YOU WORK WITH A LITTLE VESSEL OR ATHEROSCLEROTIC VESSEL.¿ ALSO INDICATED VESSEL PERFORATION STATING: ¿SIMILAR SITUATION AS BEFORE¿ ALSO INDICATED MAJOR BLEEDING ¿OUR EXPERIENCE IS ALMOST ALWAYS WHEN THE CATHETER IS USED BY PEOPLE WITHOUT ENOUGH TRAINING. ALMOST ALWAYS IS IN ARTERY VESSELS NEAR OF THORACIC LOCATIONS.¿ THE DEVICES WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2811779 UNK - PRODUCT - CORDIS CORPORATION WIRE, GUIDE, CATHETER DQX CORDIS US. CORP UNK - PRODUCT - CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown