BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN TRANSRADIAL SHEATH

    MDR report key: 14835246 · Received June 27, 2022

    Report

    Report Number
    9616099-2022-05762
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    May 31, 2022
    Report Date
    June 27, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    OEX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED IN THE TRANSRADIAL SHEATHS PMS SURVEY THE RESPONDENT INDICATED INABILITY TO USE THE RAIN RADIAL SHEATH SUCCESSFULLY WITH ACCESS COMPLICATIONS, SHEATH KINKING, SPASM, THROMBOSIS AND DISSECTION. 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 ¿CATHETER SHEATH INTRODUCER (CSI)- KINKED/BENT, VASCULAR ACCESS COMPLICATION, VASOSPASM, THROMBOSIS, AND VASCULAR DISSECTION¿ COULD NOT BE CONFIRMED. THE CAUSE OF THE KINKED/BENT CONDITION AND VASCULAR ACCESS COMPLICATION CANNOT BE CONCLUSIVELY DETERMINED WITH THE LIMITED INFORMATION AVAILABLE. VASOSPASM, THROMBOSIS, AND DISSECTION/INTIMAL TEAR ARE KNOWN COMPLICATIONS AND ARE LISTED IN THE IFU AS SUCH. 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, ¿POSSIBLE COMPLICATIONS INCLUDE, BUT ARE NOT LIMITED TO: ABRUPT VESSEL CLOSURE, ADDITIONAL INTERVENTION, ALLERGIC REACTION (DEVICE, CONTRAST MEDIUM AND MEDICATIONS), AIR EMBOLISM, INFECTION, INTIMAL TEAR, HEMATOMA AT PUNCTURE, HEMORRHAGE, INFLAMMATION / INFECTION / SEPSIS, ISCHEMIA, PERFORATION OF VESSEL WALL, THROMBUS FORMATION, PERIPHERAL NERVE INJURY, PAIN, VASCULAR COMPLICATIONS (E.G. INTIMAL TEAR, DISSECTION, PSEUDO ANEURYSM, PERFORATION, RUPTURE, SPASM, OCCLUSION). TO PREVENT DAMAGE TO THE CSI TIP OR KINKING OF THE CSI BODY, DO NOT WITHDRAW THE VESSEL DILATOR WHILE ADVANCING AND POSITIONING THE CSI IN THE VESSEL.¿ 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 THE TRANSRADIAL SHEATHS PMS SURVEY THE RESPONDENT INDICATED INABILITY TO USE THE RAIN RADIAL SHEATH SUCCESSFULLY WITH ACCESS COMPLICATIONS, SHEATH KINKING, SPASM, THROMBOSIS AND DISSECTION. THE DEVICE IS NOT AVAILABLE FOR ANALYSIS. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1937900 UNKNOWN TRANSRADIAL SHEATH CADRIOVASCULAR CATHETER SHEATH INTRODUCER KIT OEX CORDIS CORPORATION UNKTRANSRADIALSHEATH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK.