BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DGW .035 FC STR 150CM TEF LT

    MDR report key: 10962902 · Received December 7, 2020

    Report

    Report Number
    1016427-2020-04610
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 9, 2020
    Report Date
    February 1, 2021
    Manufacturer
    LAKE REGION
    Product Code
    DQX
    PMA / PMN Number
    K864058
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE MEDICAL DEVICE REPORTING REFERENCE NUMBER FOR THE OTHER EVENT IS 1016427-2020-04609. THE HEAD-TIP OF TWO (2) .035" 150CM X 10CM EMERALD FIXED-CORE STRAIGHT TIP DIAGNOSTIC GUIDEWIRES (DGW) WERE DESQUAMATED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. TWO NON-STERILE EMERALD FIXED-CORE STRAIGHT TIP DIAGNOSTIC GUIDEWIRES (DGW .035 FC STR 150CM TEF LT) WERE RECEIVED FOR ANALYSIS. THE PRODUCTS WERE IDENTIFIED WITH NUMBER ONE AND TWO WITH THE PURPOSE OF PERFORMING A SEPARATE EVALUATION. THE GUIDEWIRE IDENTIFIED AS NUMBER ONE IS EVALUATED IN THIS COMPLAINT FILE (B)(4). THE OTHER GUIDEWIRE IS EVALUATED IN A DIFFERENT COMPLAINT FILE ((B)(4) REPORT 1016427-2020-04609). PER VISUAL ANALYSIS, THE DEVICE WAS THOROUGHLY INSPECTED AND NO DELAMINATION CONDITION ON THE COATING WAS OBSERVED. HOWEVER, A KINKED/BENT CONDITION WAS PRESENT LOCATED AT 9 CM FROM THE PROXIMAL END. NO OTHER DAMAGES OR ANOMALIES WERE NOTICED. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35233660 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED ¿COATING-WIRES -DELAMINATED¿ WAS NOT CONFIRMED FOR BOTH WIRES AS THE UNITS DO NOT PRESENT ANY COATING DELAMINATION CONDITION. HOWEVER, A KINKED/BENT CONDITION WAS OBSERVED ON BOTH RETURNED DEVICES. THE CAUSE OF THIS DAMAGE OBSERVED ON THE RETURNED GUIDEWIRES COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿DO NOT USE IF PACKAGE IS OPEN OR DAMAGED. USE PRIOR TO ¿USE BY¿ DATE. DO NOT EXPOSE TO ORGANIC SOLVENTS. EXPOSURE TO TEMPERATURES ABOVE 54°C (130°F) MAY DAMAGE THE COMPONENTS. DO NOT WITHDRAW A PTFE COATED GUIDEWIRE THROUGH A METAL-CANNULA NEEDLE. WITHDRAWAL MAY DAMAGE THE GUIDEWIRE COATING. IF STRONG RESISTANCE IS MET DURING MANIPULATION, DISCONTINUE THE PROCEDURE AND DETERMINE THE CAUSE OF RESISTANCE BEFORE PROCEEDING. IF THE CAUSE OF THE RESISTANCE CANNOT BE DETERMINED, WITHDRAW THE CATHETER AND GUIDEWIRE.¿ NEITHER THE PHR REVIEW NOR THE PRODUCT ANALYSES SUGGEST THAT THE EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE MEDICAL DEVICE REPORTING REFERENCE NUMBER FOR THE OTHER EVENT IS 1016427-2020-04609. THE HEAD-TIP OF TWO (2) .035" 150CM X 10CM EMERALD FIXED-CORE STRAIGHT TIP DIAGNOSTIC GUIDEWIRES (DGW) WERE DESQUAMATED. THERE WAS NO REPORTED PATIENT INJURY. ADDITIONAL PROCEDURAL DETAILS WERE REQUESTED BUT NOT PROVIDED. THE DEVICES WERE NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 35233660 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICES AND THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICES FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿COATING-WIRES DELAMINATED¿ COULD NOT BE CONFIRMED AND THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. PROCEDURAL/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. PER THE INSTRUCTIONS FOR USE (IFU), WHICH IS NOT INTENDED AS A MITIGATION OF RISK, ¿GUIDEWIRES ARE DELICATE INSTRUMENTS AND SHOULD BE HANDLED CAREFULLY. PRIOR TO USE AND WHEN POSSIBLE DURING THE PROCEDURE, INSPECT THE GUIDEWIRE CAREFULLY FOR SIGNS OF DAMAGE. DO NOT USE A GUIDEWIRE THAT SHOWS SIGNS OF DAMAGE. NEVER PUSH, AUGER, WITHDRAW, OR TORQUE A GUIDEWIRE THAT MEETS RESISTANCE. STOP THE PROCEDURE. DO NOT MOVE OR TORQUE THE GUIDEWIRE. FIRST, USING FLUOROSCOPY, DETERMINE THE CAUSE OF RESISTANCE AND TAKE ANY NECESSARY REMEDIAL ACTION. TORQUING OR PUSHING A GUIDEWIRE AGAINST RESISTANCE MAY CAUSE GUIDEWIRE DAMAGE, AND/OR GUIDEWIRE TIP SEPARATION, OR DIRECT DAMAGE TO THE VESSEL. RESISTANCE MAY BE FELT AND/OR OBSERVED (VIA FLUOROSCOPY) BY NOTING ANY BUCKLING OF THE GUIDEWIRE TIP. IF GUIDEWIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION; OTHERWISE DAMAGE TO THE GUIDEWIRE MAY OCCUR. MOVEMENT OF TORQUE DEVICE OR METAL INSERTION TOOL ON A GUIDEWIRE'S COATING MAY COMPROMISE THE INTEGRITY OF THE COATING.¿ NEITHER THE PHR REVIEW NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE EVENT COULD BE RELATED TO THE MANUFACTURING PROCESS OF THE UNIT. THEREFORE, NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS IS ONE OF TWO PRODUCTS INVOLVED WITH THE REPORTED EVENT. THE MEDICAL DEVICE REPORTING REFERENCE NUMBER FOR THE OTHER EVENT IS 1016427-2020-04609. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THIS DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS REPORTED, THE HEAD-TIP OF TWO (2) .035" 150CM X 10CM EMERALD FIXED-CORE STRAIGHT TIP DIAGNOSTIC GUIDEWIRES (DGW) WERE DESQUAMATED. THERE WAS NO REPORTED PATIENT INJURY. THE DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1428148 DGW .035 FC STR 150CM TEF LT WIRE, GUIDE, CATHETER DQX LAKE REGION 502544 35233660

    Patients

    Seq Age Sex Outcome Treatment
    1