BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 2082608 · Received May 10, 2011

    Report

    Report Number
    9616099-2011-00314
    Event Type
    Malfunction
    Date Received
    May 10, 2011
    Date of Event
    April 15, 2011
    Report Date
    April 18, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DEVICE WAS RECEIVED AND WAS UPDATED ACCORDINGLY. WHILE ATTEMPTING TO CANNULATE A SEVERELY CALCIFIED, MODERATELY ANGULATED RIGHT CORONARY ARTERY WITH A 95% STENOSIS THE PHYSICIAN HAD TO UTILIZE A LOT OF TORQUING DURING ADVANCEMENT OF THE GUIDING CATHETER THROUGH VERY TORTUOUS ANATOMY. DURING REMOVAL OF THE GUIDING CATHETER THE JR 4 BROKE INTO TWO SEPARATE PIECES WHEN THE HUB SEPARATED FROM THE CATHETER. THE SEPARATED HUB WAS RETRIEVED BY PULLING THE SEPARATED CATHETER RIGHT AT THE HUB OUT FROM THE PATIENT. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICE WAS REMOVED FROM THE PACKAGE AND NONE NOTED DURING PREP OF THE DEVICE. THERE WAS NO REPORTED PATIENT INJURY. ONE NON STERILE UNIT OF VISTA BRITE TIP GC 6F .070 WAS RECEIVED SEPARATED IN TWO PIECES AT 4.4 CM FROM HUB IN A PLASTIC BAG; BLOOD RESIDUES WERE OBSERVED AT SEPARATION POINTS. VISUAL INSPECTION REVEALED SEVERAL DAMAGES THROUGHOUT THE CATHETER'S BODY. KINKS WERE DETECTED AT 43.5 CM, 54.0 CM, AND 68.5 CM, FROM HUB. COMPRESS SECTION FROM BRITE TIP DISTAL END TO 1.3 CM. THE SAMPLE ALSO EXHIBITED TWISTING AND ELONGATION CHARACTERISTIC AT THE SEPARATION POINTS. SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS WAS PERFORMED TO THE PART IN ORDER TO IDENTIFY THE SOURCE OF THE "SEPARATED" CONDITION; THE RESULTS ARE THE FOLLOWING: "RESULTS SHOWED THAT THE GUIDING CATHETER SURFACES PRESENTED EVIDENCE OF TWISTING, BENDING AND SMEARING CHARACTERISTICS. REVERSE BENDING, TWISTING AND/OR PULLING COULD BE RELATED TO THESE SURFACE CHARACTERISTICS. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO CUTTING CHARACTERISTICS WERE OBSERVED IN THE BODY OF THE CATHETER AND/OR IN THE BRAID WIRE". A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. AS ADDITIONAL INFORMATION, THE FOLLOWING INVESTIGATION WAS PERFORMED: THE MANUFACTURING PROCESS WAS REVIEW FOR A POTENTIAL TOOLING OR EQUIPMENT THAT COULD CAUSE THE SEPARATED CONDITION ON THE CATHETER; AND THERE IS NOT TOOLING, EQUIPMENT OR PRODUCT HANDLING DURING THE GUIDING CATHETER MANUFACTURING PROCESS THAT COULD CAUSE THE TYPE OF DAMAGES FOUND ON THE COMPLIANT UNIT. NO SIMILAR INTERNAL NON CONFORMANCES HAVE BEEN REPORTED IN THE LAST 24 MONTHS. THE COMPLAINT REPORTED BY THE CUSTOMER "LUER HUB SEPARATED" WAS NOT CONFIRMED; HOWEVER, DURING THE ANALYSIS, IT WAS FOUND THAT CATHETER BODY/SHAFT WAS SEPARATED AT 4.4 CM FROM HUB. THE CAUSE OF THE SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. NEITHER THE ANALYSIS NOR THE SCANNING ELECTRON MICROSCOPE (SEM) ANALYSIS RESULTS SUGGEST THAT THE REPORTED FAILURE IS RELATED TO THE MANUFACTURING PROCESS. PROCEDURAL FACTORS AND THE HEAVY MANIPULATION OF THE CATHETER DURING THE PROCEDURE MAY CONTRIBUTE TO THE FAILURE AS REPORTED. CONTROLS ARE IN PLACE TO VERIFY THE CATHETER FOR THESE CONDITIONS; THE PRODUCED CATHETERS ARE INSPECTED 100 % BEFORE LEAVING THE FACILITY. SEVERAL INSPECTIONS ARE PERFORMED THROUGHOUT ALL THE GUIDING CATHETER ASSEMBLY PROCESS OPERATIONS. THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE PATIENT'S DIFFICULT ANATOMY AND PROCEDURAL MANIPULATION MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: CORDIS VISTA BRITE TIP GUIDING CATHETERS CATALOG NUMBER 67019090, LOT NUMBER 15202490 AND CATALOG NUMBER 67009000, LOT NUMBER 15329554. DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. THE PRODUCT WAS RETURNED FOR ANALYSIS WHICH IS PENDING. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM INDICATED THAT 3 GUIDING CATHETERS WERE UTILIZED IN A PATIENT WITH VERY TORTUOUS VESSELS. THE INTENDED PROCEDURE WAS TO ACCESS AND INTERVENE IN THE RCA. THE LESION WAS SEVERELY CALCIFIED, HAD MODERATE ANGULATION AND 95% STENOSIS. THE PHYSICIAN UTILIZED A LOT OF TORQUING TO TRY AND CANNULATE THE VESSELS, BUT WAS UNABLE TO ACHIEVE DESIRED EFFECT. AS YOU'LL SEE (WILL BE SHIPPING ALL 3 CATHETERS FOR INSPECTION), THE JR4 ST KINKED AND SHOULD NOT HAVE, THE JR 4 BROKE INTO TWO SEPARATE PIECES WHEN THE HUB SEPARATED FROM THE CATHETER, AND THE IM CATHETER WOULD NOT TORQUE. THE SEPARATED HUB RETRIEVED BY PULLING THE SEPARATED CATHETER RIGHT AT THE HUB OUT FROM THE PATIENT. THERE WAS NO NEED FOR ADDITIONAL TOOLS TO REMOVE THE PRODUCT. THE PATIENT RETURNED A FEW DAYS LATER, NEW CATHETERS WERE UTILIZED AND THE PHYSICIAN WAS ABLE TO CANNULATE THE OSTIUM AND PLACE A STENT. THE PATIENT SUFFERED NO INJURY BUT THE PHYSICIAN WAS QUITE UNHAPPY WITH THE CATHETERS FALLING APART AND NOT BEING PROPERLY HELD UP TO ITS USUAL STANDARD OF QUALITY. THERE WERE NO ANOMALIES NOTED WHEN THE DEVICES WERE REMOVED FROM THE PACKAGES AND NONE NOTED DURING PREP OF ANY OF THE DEVICES. THE DEVICES WERE NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15330545

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR