BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLOSUREFAST CATHETER

    MDR report key: 6714394 · Received July 14, 2017

    Report

    Report Number
    2183870-2017-00306
    Event Type
    Malfunction
    Date Received
    July 14, 2017
    Date of Event
    June 16, 2017
    Report Date
    January 30, 2018
    Manufacturer
    COVIDIEN
    Product Code
    GEI
    PMA / PMN Number
    K111887
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATION SUMMARY: THE CLOSUREFAST CATHETER WAS RETURNED FOR ANALYSIS. ONE IMAGE WAS ALSO RECEIVED FROM THE CUSTOMER - THE IMAGE REVEALED A COMPARISON OF TWO CATHETERS WITH ONE CATHETER OBSERVED TO HAVE COIL SEPARATION FROM THE CATHETER SHAFT LUMEN. THE IMAGE ALSO REVEALS A MISSING BALL TIP OF THE DISTAL END OF THE CATHETER. THE CATHETER WAS EXAMINED. VISUAL INSPECTION OF THE CATHETER REVEALED COIL SEPARATION FROM CATHETER SHAFT LUMEN. THE COIL AND SIGNAL WIRE WERE OBSERVED TO BE DETACHED. THE TIP BALL ON THE DISTAL TIP WAS MISSING. THE COIL WINDING AND THE DETACHED TIP WERE NOT RETURNED. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE BALL TIP AND COIL THAT HAD THROMBOSED IN THE PATIENT WERE NOT RETRIEVED. A FOLLOW-UP ULTRASOUND EXAMINATION SHOWED THAT IT WAS COMPLETELY SURROUNDED IN THROMBUS, LOCATED AT PROXIMAL GSV ATLEAST 3-4 CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ). IT WAS ALSO REPORTED THAT THERE WAS A HIGH DEGREE OF RESISTANCE ON CATHETER WHEN PULLED BACK, PHYSICIAN STATED HE REALLY HAD TO PULL IT OUT WITH STRONG PULL. NO ADVERSE EVENTS WITH PATIENT REPORTED. IT WAS REPORTED THAT PATIENT OPTED TO NOT HAVE ANY THROMBOSED PIECES REMOVED. PATIENT'S CURRENT STATUS WAS REPORTED AS GOOD. PATIENT HAD NO DISCOMFORT OR PAIN. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: PER ADDITIONAL ANALYSIS, OPTICAL AND SCANNING ELECTRON MICROSCOPY (SEM) IMAGES OF COMPLAINT DEVICE WITH THE MISSING OUTER SHEATH, SHOW EVIDENCE OF A DEGRADED SUBSTRATE MATERIAL WITH SIGNIFICANT HOLES AND MISSING MATERIAL. THE IMAGES ALSO SHOW STRANDS OF POLYMER WHERE THE OUTER SHEATH IS MISSING THAT APPEAR TO HAVE BEEN MELTED AND PULLED APART. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    CORRECTED DATA: DEVICE RETURN DATE ORIGINALLY REPORTED AS 16-JUN-2017. CORRECT DEVICE RETURN DATE WAS 26-JUN-2017. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    PHYSICIAN USED A CLOSUREFAST CATHETER FOR A RADIOFREQUENCY ABLATION PROCEDURE OF THE GREAT SAPHENOUS VEIN (GSV) UNDER LOCAL ANESTHESIA. THE DEVICE IFU WAS FOLLOWED. LUMEN FLUSHED BEFORE USE. A GUIDEWIRE WAS NOT USED FOR INSERTION OF THE CATHETER. DURING THE PROCEDURE ONE KINK WAS OBSERVED ON THE COIL OF THE CATHETER. THE PHYSICIAN HAS REPORTED THAT THE CATHETER WAS PLACED 3.1 CM FROM THE SAPHENOFEMORAL JUNCTION (SFJ) AND AT THAT TIME PHYSICIAN TREATED PROXIMAL SEGMENT 3-4X AND WHEN HE ATTEMPTED TO PULL BACK TO THE NEXT SEGMENT, THE CATHETER WAS RESISTANT. IT IS REPORTED THAT THE CATHETER WAS OBSERVED TO BE KINKED AT THIS TIME UNDER ULTRASOUND AND WHEN THE CATHETER EVENTUALLY RELEASED, THE COIL WAS THROMBOSED AT THE SFJ AND NOT ATTACHED TO THE CATHETER ANY LONGER. PHYSICIAN REPORTS THE CATHETER WAS REMOVED AND THE PROCEDURE WAS COMPLETED USING A SECOND DEVICE. NO ADDITIONAL TREATMENT REQUIRED. NO PATIENT INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    494713 CLOSUREFAST CATHETER ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES GEI COVIDIEN CF7-7-60 553609X

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR