BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER

    MDR report key: 2926201 · Received January 14, 2013

    Report

    Report Number
    1820334-2013-00027
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 14, 2012
    Report Date
    December 17, 2012
    Manufacturer
    COOK, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A VISUAL EXAMINATION OF THE RETURNED PRODUCT AND THE PROVIDED PHOTO IMAGES REVEALED THE CATHETER TIP HAD SEPARATED. DURING INVESTIGATION, A REVIEW OF COMPLAINT HISTORY, REVIEW OF DEVICE HISTORY RECORD, REVIEW OF IFU, REVIEW OF QC, AND A REVIEW OF TRENDS WAS PERFORMED. THIS CATHETER IS 100% INSPECTED FOR SURFACE INTEGRITY AND IS INSPECTED VIA RANDOM SAMPLE FOR TIP BOND STRENGTH. PER QC SPEC, THERE IS A PULL TEST INSPECTION ON EACH ORDER RECEIVED. IN ADDITION, THERE IS 100% INSPECTION, VERIFYING THE SURFACE OF THE CATHETER IS FREE OF DAMAGE AND EXCESS BUMPS OR ROUGHNESS. THE WIRE BRAIDED CATHETER SURFACE MUST ALSO BE FREE OF EXPOSED WIRES. AN INSTRUCTIONS FOR USE IS PROVIDED THAT STATES, "DUE TO THINWALL CONSTRUCTION, EXTREME CARE MUST BE EXERCISED DURING MANIPULATION AND WITHDRAWAL. CATHETER INSERTION THROUGH A SYNTHETIC VASCULAR GRAFT SHOULD BE AVOIDED WHENEVER POSSIBLE" AND "STORE IN A DARK, DRY, COOL PLACE. AVOID EXTENDED EXPOSURE TO LIGHT. UPON REMOVAL FROM PACKAGE, INSPECT THE PRODUCT TO ENSURE NO DAMAGE HAS OCCURRED." A CHANGE REQUEST WAS EFFECTIVE (B)(4) 2010 WITH THE REVISION TO INCLUDE IMPROVED BONDING PROCESSES AND SET-UP PROCEDURES. THE IIP BONDING PROCESS FOR HNR4.0 CATHETERS HAS BEEN VALIDATED. THE PROVIDED PHOTOS SHOW THE CATHETER SEPARATED A SHORT DISTANCE BEYOND THE TIP BOND SITE INDICATING MATERIAL FAILURE, NOT BOND FAILURE, AFTER CATCHING ON VESSEL CALCIFICATION AND BEING SUBJECTED TO TENSILE FORCES BEYOND IT'S DESIGN STRENGTH. THE APPROPRIATE INTERNAL PERSONNEL HAVE BEEN NOTIFIED AND WE ARE CONTINUING TO MONITOR COMPLAINTS FOR SIMILAR EVENTS.

    Description of Event or Problem · 1

    THE CATHETER WAS USED IN AN ANGIOPLASTY PROCEDURE. WHEN THE DR WAS REMOVING THE PRODUCT FROM THE PT, THE PIG TAIL END SNAPPED OFF AND REMAINED IN THE PT. THE DR HAD TO USE A SNARE TO RETRIEVE FROM PT. UPDATE AS PER COMPLAINT FORM RECEIVED (B)(4) 2012: "THE RADIOLOGIST WAS PERFORMING AN ANGIOPLASTY ON A PT WITH CALCIFIED VESSELS. HE PULLED OUT THE CATHETER WITH HARDLY ANY FORCE; HOWEVER, THE CATHETER WAS CAUGHT ON AN AREA OF CALCIFICATION AND THE TIP OF THE CATHETER CAME OFF. IT WAS RETRIEVED FROM INSIDE THE PT USING A SNARE." THE PT WAS SUBJECTED TO FURTHER X-RAY SCREENING. THE COMPLAINANT DID NOT REPORT ANY ADVERSE EFFECTS ON THE PT DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19912 BEACON TIP ROYAL FLUSH PLUS FLUSH CATHETER DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO COOK, INC. NA 3694022

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention