BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAIN SHEATH TRANSRADIAL

    MDR report key: 18023477 · Received October 27, 2023

    Report

    Report Number
    9616099-2023-06620
    Event Type
    Malfunction
    Date Received
    October 27, 2023
    Date of Event
    February 18, 2023
    Report Date
    January 4, 2024
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DYB
    UDI-DI
    10705032078948
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE TIP OF THE DILATOR OF A 6F 10CM SF RAIN SHEATH TRANS-RADIAL THIN-WALLED SHEATH WAS CRUSHED, UPON OPENING. IT WAS PURGED AND THE SOLUTION CAME OUT FROM THE SIDE. THEREFORE, THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RAIN SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE PACKAGING OR SHIPPING BOX OF THE DEVICE. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). A NON- STERILE ¿6F,10CM SW RADIAL" WAS RECEIVED FOR ANALYSIS. THE VESSEL DILATOR, MINI GUIDEWIRE, AND THE CATHETER SHEATH INTRODUCER (CSI) WERE RETURNED FOR ANALYSIS. A FRAYED CONDITION ON THE DISTAL TIP OF THE VESSEL DILATOR WAS NOTED DURING VISUAL ANALYSIS. NO DAMAGES WERE NOTED TO THE MINI GUIDEWIRE OR THE CSI. MICROSCOPIC ANALYSIS CONFIRMED THE FRAYED CONDITION ON THE DISTAL TIP OF THE VESSEL DILATOR. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18133128REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿VESSEL DILATOR~COMPRESSED/CRUSHED¿ WAS NOT CONFIRMED. THE VESSEL DILATOR DID NOT PRESENT WITH A COMPRESSED CONDITION. HOWEVER, THE MALFUNCTION ¿VESSEL DILATOR~FRAYED/SPLIT/TORN¿ WAS CONFIRMED, A FRAYED CONDITION WAS OBSERVED ON THE DISTAL TIP OF THE VESSEL DILATOR. THE EXACT CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. HANDLING FACTORS WHILE PREPARING THE DEVICE MAY HAVE CONTRIBUTED TO THIS ISSUE. 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, ¿CAREFULLY REMOVE CSI FROM PACKAGE USING STERILE TECHNIQUE. INSPECT THE SYSTEM CONTENTS FOR ANY SIGNS OF DAMAGE; DO NOT USE IF ANY DAMAGE IS PRESENT.¿ 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

    A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH LOT 18133128 PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED EVENT. THIS DEVICE HAS BEEN ANALYZED BUT THE FINAL, APPROVED DRAFT OF THE ENGINEERING REPORT AND ITS CONCLUSION IS NOT YET AVAILABLE DUE TO NEED FOR ADDITIONAL TESTING. HOWEVER, IT WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE TIP OF THE DILATOR OF A 6F 10CM SF RAIN SHEATH TRANS-RADIAL THIN-WALLED SHEATH WAS CRUSHED, UPON OPENING. IT WAS PURGED AND THE SOLUTION CAME OUT FROM THE SIDE. THEREFORE, THE DEVICE WAS NOT INTRODUCED INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RAIN SHEATH. THERE WERE NO REPORTS OF PATIENT INJURY. THERE WERE NO DAMAGES NOTED ON THE PACKAGING OR SHIPPING BOX OF THE DEVICE. THE DEVICE WAS STORED AND PREPPED IN ACCORDANCE WITH THE INSTRUCTIONS FOR USE (IFU). THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. ADDENDUM: PRODUCT EVALUATION SHOWS A FRAYED CONDITION ON THE DISTAL TIP OF THE VESSEL DILATOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2206583 RAIN SHEATH TRANSRADIAL INTRODUCER, CATHETER DYB CORDIS CORPORATION 18133128 10705032078948

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown ANOTHER UNKNOWN RAIN SHEATH.