BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6F10CM SW RADIAL

    MDR report key: 12455062 · Received September 10, 2021

    Report

    Report Number
    9616099-2021-04855
    Event Type
    Malfunction
    Date Received
    September 10, 2021
    Date of Event
    January 1, 1980
    Report Date
    September 10, 2021
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K181592
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, THE HYDROPHILIC COATING OF A 6F 10CM TRANS-RADIAL RAIN SHEATH STRIPPED OFF UPON ATTEMPTING TO INSERT IT INTO THE PATIENT FOR A DIAGNOSTIC PROCEDURE. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU) IN A CLIMATE-CONTROLLED AREA. THE DEVICE WAS STORED FOR ONE MONTH BEFORE ATTEMPTING TO USE. THE DEVICE WAS OPENED IN A STERILE FIELD AND USED IN PATIENT. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THERE NO DO DIFFICULTY EXPERIENCED WHILE PREPPING THE DEVICE. THE CSI WAS WIPED DOWN WITH A WET GAUZE AND HYDRATED BEFORE INSERTION. THE CSI WAS EXPOSED TO AIR FOR 15 MINUTES PRIOR TO ATTEMPTING TO IN INSERT INTO THE PATIENT. THE COATING WAS NOTED TO COME OFF FROM THE DISTAL PORTION OF THE CSI. THE CASE WAS COMPLETED AFTER THEY REMOVED THE RAIN SHEATH AND CHANGED TO A NON-CORDIS SHEATH. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿COATING-SHEATHS-SEPARATED IN-PATIENT¿ WAS UNABLE TO BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ACCORDING TO THE IFU, WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿CAREFULLY REMOVE CSI FROM PACKAGE USING STERILE TECHNIQUE. CAUTION: TO PREVENT DAMAGE WHILE REMOVING SHEATH FROM PACKAGE, GENTLY PULL UP THE SIDE PORT (AT THE SHEATH HUB) TO REMOVE FROM THE PACKAGE. INSPECT THE SYSTEM CONTENTS FOR ANY SIGNS OF DAMAGE; DO NOT USE IF ANY DAMAGE IS PRESENT. SOAK THE CSI IN STERILE HEPARINIZED SALINE OR SIMILAR ISOTONIC SOLUTION TO ACTIVATE THE HYDROPHILIC COATING. IF USING A HYDROPHILIC ACCESS WIRE, SOAK THE WIRE AS WELL TO ACTIVATE THE COATING.¿ ADDITIONALLY, THE IFU CAUTIONS USERS ¿IF RESISTANCE IS FELT UPON INSERTION OR WITHDRAWAL, INVESTIGATE THE CAUSE BEFORE CONTINUING.¿ AS NOT LOT NUMBER WAS PROVIDED A PHR COULD NOT BE GENERATED. THE ROOT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, AN INCREASE IN COMPLAINTS FOR THIS ISSUE HAS BEEN IDENTIFIED AND COULD BE POSSIBLY RELATED TO THE MANUFACTURING PROCESS; THEREFORE, A RISK ASSESSMENT TO ADDRESS THIS ISSUE HAS BEEN INITIATED.

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER TO CONDUCT A DEVICE HISTORY RECORD (DHR) REVIEW, IT IS NOT POSSIBLE TO DETERMINE IF THE REPORTED FAILURE COULD BE RELATED TO THE MANUFACTURING PROCESS. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE HYDROPHILIC COATING OF A 6F 10CM TRANS-RADIAL RAIN SHEATH STRIPPED OFF UPON ATTEMPTING TO INSERT INTO THE PATIENT FOR A DIAGNOSTIC PROCEDURE. THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS STORED PER THE INSTRUCTIONS FOR USE (IFU) IN A CLIMATE-CONTROLLED AREA. THE DEVICE WAS STORED FOR ONE MONTH BEFORE ATTEMPTING TO USE. THE DEVICE WAS OPENED IN A STERILE FIELD AND USED IN PATIENT. NO DAMAGE WAS NOTED TO THE PRODUCT PACKAGING. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE. THERE NO DO DIFFICULTY EXPERIENCED WHILE PREPPING THE DEVICE. THE CSI WAS WIPED DOWN WITH A WET GAUZE AND HYDRATED BEFORE INSERTION. THE CSI WAS EXPOSED TO AIR FOR 15 MINUTES PRIOR TO ATTEMPTING TO IN INSERT INTO THE PATIENT. THE COATING WAS NOTED TO COME OFF FROM THE DISTAL PORTION OF THE CSI. THE CASE WAS COMPLETED AFTER THEY REMOVED THE RAIN SHEATH BEFORE INSERTING AND CHANGED TO A NON-CORDIS SHEATH. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1350469 6F10CM SW RADIAL INTRODUCER, CATHETER DYB CORDIS CORPORATION 506610S UNK

    Patients

    Seq Age Sex Outcome Treatment
    1