BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP IG INTRODUCER GUIDING CATHETERS

    MDR report key: 2900215 · Received January 7, 2013

    Report

    Report Number
    9616099-2013-00015
    Event Type
    Malfunction
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 17, 2012
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K001136
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING; HOWEVER, IT HAS NOT BEEN RECEIVED TO DATE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE VISTA BRITE TIP IG INTRODUCER GUIDING CATHETER WAS INSERTED WITH THE INTRODUCER IN PLACE. WHEN THE PHYSICIAN TRIED TO TAKE OUT THE INTRODUCER, IT WOULD NOT COME OUT. THE HUB THEN CAME OFF THE INTRODUCER WHEN THEY TRIED TO GET THE INTRODUCER OUT. THE PATIENT WAS THEN SUCCESSFULLY TREATED WITH ANOTHER SHEATH. NO PATIENT OR PROCEDURAL INFORMATION WAS PROVIDED. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. ONE NON STERILE UNIT OF INTRO G 7F RDC I 55CM .035" WAS RECEIVED FOR ANALYSIS INSIDE OF A PLASTIC BAG WITH A VESSEL DILATOR WITH MOLDED HUB DETACHED (MOLDED HUB AND A SMALL PORTION OF VESSEL DILATOR BODY WERE RECEIVED INSIDE OF A SMALL PLASTIC BAG). THE GUIDING CATHETER WAS RECEIVED COILED BUT WITHOUT KINKED/BENT. NO OTHER VISUAL ANOMALY WAS OBSERVED ON THE RECEIVED UNITS. THE GUIDING CATHETER ID WAS MEASURED AT SEVERAL LOCATIONS AND THE VESSEL DILATOR OD WAS MEASURED AT SEVERAL LOCATIONS AND RESULTS WERE FOUND WITHIN SPECIFICATION. THE VESSEL DILATOR WAS SENT TO ANALYSIS IN ORDER TO IDENTIFY THE CAUSE OF HUB SEPARATION AND THE RESULTS SHOW THAT: 'THE HUB/BODY SURFACES PRESENTED EVIDENCE OF ELONGATION AT THE SURROUNDINGS OF THE SEPARATION. ELONGATION IS A COMMON CHARACTERISTIC OF PIECES WHICH WERE STRETCHED/ PULLED UNTIL SEPARATION. STRETCHING/ PULLING COULD HAVE BEEN RELATED TO THESE SEPARATION CHARACTERISTICS; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE EXACT CAUSE OF THE HUB AND BODY SEPARATION COULD NOT BE CONCLUSIVELY DETERMINED¿. THE GUIDING CATHETER (GC) WAS FLUSHED WITH WATER AND THE VESSEL DILATOR PORTION WITHOUT HUB WAS INSERTED ON IT, THE VESSEL DILATOR ADVANCED THROUGH GC WITHOUT ANY DIFFICULTY, NO RESISTANCE OR FRICTION WAS FELT DURING INSERTION/WITHDRAWN. 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. THE FAILURE 'CATHETER (BODY/SHAFT)-WITHDRAWAL DIFFICULTY-THROUGH SHEATH' WAS NOT CONFIRMED SINCE NO RESISTANCE OR FRICTION WAS FELT DURING INSERTION/WITHDRAWN TEST. THE REPORTED CUSTOMER COMPLAINT OF VESSEL DILATOR HUB SEPARATION WAS CONFIRMED THROUGH ANALYSIS; HOWEVER THE EXACT CAUSE OF THIS EVENT COULD NOT BE CONCLUSIVELY DETERMINED. WITH THE LIMITED INFORMATION PROVIDED IT IS NOT POSSIBLE TO DETERMINE AN EXACT CAUSE FOR THE FAILURE EXPERIENCED BY THE CUSTOMER. THERE IS NOTHING IN THE ANALYSIS OR THE DEVICE HISTORY REPORT REVIEW TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    AS REPORTED, THE VISTA BRITE TIP IG INTRODUCER GUIDING CATHETER WAS INSERTED WITH THE INTRODUCER IN PLACE. WHEN THE PHYSICIAN TRIED TO TAKE OUT THE INTRODUCER, IT WOULD NOT COME OUT. THE HUB THEN CAME OFF THE INTRODUCER WHEN THEY TRIED TO GET THE INTRODUCER OUT. THE PATIENT WAS THEN SUCCESSFULLY TREATED WITH ANOTHER SHEATH. THE PATIENT WAS NOT HURT. NO PATIENT OR PROCEDURAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6544 VISTA BRITE TIP IG INTRODUCER GUIDING CATHETERS ENDO GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 15146396

    Patients

    Seq Age Sex Outcome Treatment
    1