BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - PRODUCT - CORDIS CORPORATION

    MDR report key: 16040081 · Received December 22, 2022

    Report

    Report Number
    9616099-2022-06174
    Event Type
    Injury
    Date Received
    December 22, 2022
    Report Date
    February 6, 2023
    Manufacturer
    CORDIS US. CORP
    Product Code
    DQX
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY: B4, D4, G3, H1, H2, H3 AND H6 AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT 25 INDICATED ARTERY SPASM STATING: ¿ARTERIAL ACCESS FOR RENAL ARTERY PTCA. NO SPASM AFTER PAPAVERINE¿ 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 EVENT ¿ARTERIAL SPASM¿ COULD NOT BE CONFIRMED. THIS IS A WELL-KNOWN AND EXTENSIVELY DOCUMENTED POTENTIAL COMPLICATION OF A PERCUTANEOUS PROCEDURE. ARTERIAL SPASM MAY BE CAUSED BY DEVICE MANIPULATIONS INHERENT IN ANY PROCEDURE CAUSING ENDOTHELIAL IRRITATION. 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, ¿GUIDEWIRE MANIPULATION/TORQUING SHOULD ALWAYS BE PERFORMED UNDER FLUOROSCOPIC GUIDANCE. NEVER ADVANCE, WITHDRAW OR AUGER THE GUIDEWIRE AGAINST RESISTANCE WITHOUT FIRST DETERMINING THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY.¿ 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.

    Additional Manufacturer Narrative · 0

    SOME INFORMATION IS LIMITED DUE TO BEING A SURVEY CASE, EVENT DATE UNKNOWN DUE TO THIS BEING A SURVEY CASE. THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT 25 INDICATED ARTERY SPASM STATING: ¿ARTERIAL ACCESS FOR RENAL ARTERY PTCA. NO SPASM AFTER PAPAVERINE¿ THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED IN PERIPHERAL GUIDEWIRES SURVEY THE RESPONDENT 25 INDICATED ARTERY SPASM STATING: ¿ARTERIAL ACCESS FOR RENAL ARTERY PTCA. NO SPASM AFTER PAPAVERINE¿ THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2109660 UNK - PRODUCT - CORDIS CORPORATION WIRE, GUIDE, CATHETER DQX CORDIS US. CORP UNK - PRODUCT - CORDIS CORPORATION UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Life Threatening| O