BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 1953459 · Received January 10, 2011

    Report

    Report Number
    9616099-2011-00021
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 13, 2010
    Report Date
    January 26, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR ANALYSIS. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING AN INVASIVE PROCEDURE, THE TIP OF THE VISTA BRITE CATHETER CRACKED. THE TIP BROKE DURING ADVANCEMENT IN THE PATIENT, BUT IT DID NOT COMPLETELY SEPARATE. THE TARGET VESSEL HAD MODERATE TORTUOSITY AND MODERATE ANGULATION. THE DEVICE WAS A SINGLE USE DEVICE. NO ANOMALIES WERE NOTED WHEN REMOVED FROM THE PACKAGE. NO ANOMALIES NOTED DURING PREP. THE DEVICE WAS INSERTED THROUGH A HEMOSTATIC VALVE. THERE WERE NO FURTHER COMPLICATIONS WITH THE PROCEDURE. THERE WAS NO REPORT OF INJURY FOR THE PATIENT. ONE NON STERILE UNIT OF VISTA BRITE TIP GC 6F .070 WAS RECEIVED COILED IN A PLASTIC BAG; A CRACKED CONDITION WAS DETECTED AT THE 2ND SIDE HOLE, AT 3.0 CM FROM DISTAL TIP, THE CATHETER WAS BENT ON THE BACK OF THE HOLE IN THE SAME AXIS OF THE CRACKED CONDITION AND THE OUTER COATING PRESENTS PLASTIC FLASH AT THE EDGE OF THE FRACTURE (SEE ATTACHED PICTURES). KINKS WERE DETECTED THROUGHOUT THE CATHETER AT 15.3 CM, 37.4 CM, 40.3 CM, 91.8 CM AND 94.5 CM FROM DISTAL TIP. THE CATHETER OUTER AND INNER DIAMETERS WERE MEASURED NEAR TO THE CRACKED CONDITION AGAINST THE DRAWING 02A6910 REV: 30 AND THE RESULTS OF OUTER AND INNER DIAMETER WERE WITHIN SPECIFICATION. SEM ANALYSIS WAS PERFORMED TO THE UNIT IN OTHER TO IDENTIFY THE SOURCE OF THE CRACKED CONDITION; THE RESULTS ARE THE FOLLOWING: ''THE OUTER COAT PRESENTS EXTERNAL ABRASIONS, ELONGATIONS AND KINKING AT THE SURROUNDING AREAS OF THE TEAR. THERE IS EVIDENCE OF PARTIAL DELAMINATION OF THE PTFE; HOWEVER THIS APPEARS TO BE RELATED TO THE TEAR. THE PARTICLES FOUND ARE COMPOSED OF CARBON, OXYGEN, NICKEL, CHROMIUM AND IRON; THESE ARE THE MAIN COMPONENTS OF THE STAINLESS STEEL WHICH COMPOSES THE BRAID WIRE. THE EXACT CAUSE OF THIS TEAR FAILURE COULD NOT BE CONCLUSIVELY DETERMINED. DHR REVIEW WAS NOT CONDUCTED DUE TO THE COMPLAINT LOT NUMBER IS UNKNOWN. AS ADDITIONAL INVESTIGATION, A MEETING WAS HELD ON (B)(6) 2011 AT THE FAL SUPPORTED BY THE PET IN ORDER TO REVIEW THE DEFECTIVE SAMPLE AND SEM ANALYSIS REPORT AND INVESTIGATE FOR POTENTIAL CAUSE OF THE CRACKED CONDITION OBSERVED AT ONE OF THE SIDE HOLES: A. THE WHOLE MANUFACTURING PROCESS WAS REVIEWED FOR A POTENTIAL TOOLING OR EQUIPMENT THAT COULD CAUSE THE CRACKED CONDITION ON PART; AND THERE IS NO EVIDENCE OF TOOLING AND EQUIPMENT THAT COULD CAUSE THE CRACKED ISSUE ON THE CATHETER SIDE HOLE. B. PREVENTIVE MAINTENANCE RECORDS FOR SIDE HOLE MACHINES (19493E C2 & 10668E C3) WAS REVIEWED FOR A YEAR PERIOD ((B)(6) 2010- (B)(6) 2010), AND IT WAS FOUND THAT THE PREVENTIVE MAINTENANCE WAS EXECUTED DURING THE SCHEDULED TIME PERIOD UNDER WORK ORDERS. C. NO SIMILAR INTERNAL ISSUES HAVE BEEN REPORTED IN THE LAST 12 MONTHS. THE COMPLAINT REPORTED BY THE CUSTOMER ''CRACKED" WAS CONFIRMED. HOWEVER, THE CAUSE OF THE CRACKED CONDITION ON 2ND SIDE HOLE OF THE BODY/SHAFT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. HOWEVER, IT DOES NOT APPEAR TO BE MANUFACTURING RELATED. PROCEDURAL FACTORS, HANDLING AND STORAGE PROCESS MAY CONTRIBUTE TO THE FAILURE AS REPORTED. CONTROLS ARE IN PLACE TO VERIFY THE CATHETER FOR CRACKED CONDITION; THE PRODUCED CATHETERS ARE INSPECTED 100 % BEFORE LEAVING THE FACILITY. SEVERAL INSPECTIONS ARE PERFORMED THROUGH ALL THE GUIDING CATHETER ASSEMBLY PROCESS OPERATIONS. (B)(4). THEREFORE, NO CORRECTIVE AND PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THE COMPLAINT REPORTED BY THE CUSTOMER ''CRACKED'' WAS CONFIRMED. HOWEVER, THE CAUSE OF THE CRACKED CONDITION ON 2ND SIDE HOLE OF THE BODY/SHAFT COULD NOT BE CONCLUSIVELY DETERMINED DURING THE ANALYSIS. THERE IS NO EVIDENCE OF MANUFACTURING ISSUES THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. REVIEW OF THE INFORMATION SUGGESTS THAT PROCEDURAL AND VESSEL FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED FAILURE.

    Description of Event or Problem · 1

    THE AFFILIATE INDICATED THAT 6F VISTA BRITE TIP CATHETER TIP WAS BROKEN. NO ADDITIONAL INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    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 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1