BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADROIT GUIDING CATHETER

    MDR report key: 5039671 · Received August 28, 2015

    Report

    Report Number
    9616099-2015-00401
    Event Type
    Malfunction
    Date Received
    August 28, 2015
    Date of Event
    July 8, 2015
    Report Date
    July 8, 2015
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K131225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: TERUMO SHEATH. (B)(4). (B)(6). COMPLAINT CONCLUSION: DURING USE OF A 0.072¿ 6F 4 LBT ADROIT GUIDING CATHETER AND A 0.072 6F AR2 LBT GUIDING CATHETER, IT WAS REPORTED THAT THEY WERE NOT COMPATIBLE WITH THE TERUMO SHEATHS. THIS OCCURRED PRIOR TO USE ON THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY. AFTER FURTHER INVESTIGATION, THE ACCOUNT REPORTED THAT THE DEVICE LOOKED ¿CRACKED¿ WHEN IT WAS UNPACKAGED. THE DEVICES WERE STORED, HANDLED AND PREPPED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THERE WEREN¿T ANY OTHER DAMAGES OR ANOMALIES NOTED TO THE PACKAGING OR DEVICES PRIOR TO USE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ADROIT DEVICE. THE PRODUCTS WERE NOT RETURNED FOR ANALYSIS. REVIEW OF LOT 17026513 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. ACCORDING TO THE PRODUCTS INSTRUCTIONS FOR USE, USERS ARE CAUTIONED TO NOT USE OPEN OR DAMAGED PACKAGES OR PRODUCTS. BASED ON THE LIMITED INFORMATION AVAILABLE FOR REVIEW, IT IS NOT POSSIBLE TO DETERMINE WHAT FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED ISSUE. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT COULD NOT BE CONFIRMED AND NO DETERMINATION OF POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. BASED ON THE DEVICE HISTORY RECORD 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 · 1

    DURING USE OF A 0.072 6F 4 LBT ADROIT GUIDING CATHETER AND A 0.072 6F AR2 LBT GUIDING CATHETER, IT WAS REPORTED THAT THEY WERE NOT COMPATIBLE WITH THE TERUMO SHEATHS. THIS OCCURRED PRIOR TO USE ON THE PATIENT. THERE WAS NO REPORT OF PATIENT INJURY. THE DEVICES WERE DISCARDED AND WILL NOT BE RETURNED FOR ANALYSIS. ADDENDUM (8/25/2015): ADDITIONAL INFORMATION WAS RECEIVED INDICATING THAT THE DEVICE LOOKED A BIT 'CRACKED' WHEN IT WAS UNPACKAGED. THE DEVICES WERE STORED, HANDLED AND PREPPED ACCORDING TO THE IFU. THERE WEREN'T ANY OTHER DAMAGES OR ANOMALIES NOTED TO THE PACKAGING OR DEVICES PRIOR TO USE. A 6F TERUMO SHEATH INTRODUCER WAS USED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER ADROIT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571983 ADROIT GUIDING CATHETER CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS CORPORATION NA 17026513

    Patients

    Seq Age Sex Outcome Treatment
    1