BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VISTA BRITE TIP GUIDING CATHETERS

    MDR report key: 3840488 · Received May 30, 2014

    Report

    Report Number
    9616099-2014-00353
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    April 24, 2014
    Report Date
    April 25, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K021593
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT LEAKAGE IN THE PATIENT WAS CONFIRMED ON ANGIOGRAPHY. THERE WERE NO SHARP INSTRUMENTS USED DURING THE PROCEDURE. NO ANOMALIES WERE NOTED PRIOR TO INSERTING THE DEVICE INTO THE PATIENT. THE CATHETER DID NOT KINK AT ANY TIME. DURING TREATMENT OF THE RIGHT CORONARY ARTERY, IT WAS REPORTED THAT WHILE A 6F JR4 CATHETER WAS IN THE PATIENT, AIR BUBBLES WERE NOTED DURING ¿SUCK BACK¿. THE PHYSICIAN BELIEVED THERE WAS A HOLE IN THE CATHETER. LEAKAGE OF THE CATHETER WAS CONFIRMED BY ANGIOGRAPHY. THE DEVICE WAS REPLACED WITH A NEW 6F JR 4 AND NO BUBBLES WERE SEEN. THERE WAS NO REPORTED PATIENT INJURY. THE TARGET LESION WAS 100% STENOSED AND CALCIFIED. THE REFERENCED VESSEL WAS TORTUOUS, CALCIFIED AND THROMBUS LADEN. THE DEVICE APPEARED NORMAL PRIOR TO USE IN THE PATIENT AND WAS PREPPED PER THE INSTRUCTIONS FOR USE. THERE WERE NO SHARP INSTRUMENTS USED DURING THE PROCEDURE. THERE WAS NO RESISTANCE/FRICTION OR KINKING EXPERIENCED WITH THE CATHETER. BEFORE DISCOVERING THAT THERE WAS A DEFECT WITH THE GUIDING CATHETER ALL OTHER EQUIPMENT WAS CHANGED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND SHOWED THAT THIS LOT OF PRODUCTS MET ALL REQUIREMENTS PER THE APPLICABLE MANUFACTURING QUALITY PLAN. WITHOUT RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED COMPLAINT ¿CATHETER/BODY SHAFT-PUNCTURE/CUT¿ COULD NOT BE CONFIRMED AND AN EXACT CAUSE COULD NOT BE CONCLUSIVELY DETERMINED. BASED ON THE INFORMATION AVAILABLE FOR REVIEW THE DEVICE APPEARED NORMAL PRIOR TO USE AND WAS PREPPED PER THE IFU. VESSEL CHARACTERISTICS (CALCIFICATION AND STENOSIS) MAY HAVE CONTRIBUTED TO THE DIFFICULTY EXPERIENCED BY THE CUSTOMER. NEITHER THE DHR NOR THE INFORMATION AVAILABLE SUGGESTS THAT THE REPORTED COMPLAINT IS RELATED TO THE DESIGN OR MANUFACTURING PROCESS OF THE DEVICE; THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THE PATIENT'S GENDER IS UNKNOWN. 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. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    DURING TREATMENT TO THE RIGHT CORONARY ARTERY, IT WAS REPORTED THAT WHEN THE VISTA BRITE TIP GUIDING CATHETER WAS INSERTED IN THE PATIENT AND DURING "SUCK BACK", AIR BUBBLES WERE FOUND TO BE PRESENT. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PHYSICIAN BELIEVES THAT THERE WAS WHOLE IN THE CATHETER. A NEW 6F JR4 WAS USED AND NO BUBBLES WERE SEEN. THERE WAS NO PATIENT INJURY REPORTED. THE DEVICE WAS PREPPED PER IFU INSTRUCTIONS. THERE WAS NO RESISTANCE/FRICTION EXPERIENCED WITH THE VISTA BRITE. IT WAS NOTED THAT BEFORE DISCOVERING THAT THERE WAS A FAULT WITH THE CATHETER, THE PHYSICIAN CHANGED ALL THE OTHER EQUIPMENT AND FINALLY CHANGED THE GUIDING CATHETER, WHICH WAS FOUND TO BE DEFECTED. THE LESION WAS 100% STENOSED AND CALCIFIED. THE REFERENCED VESSEL WAS TORTUOUS AND THROMBUS LADEN. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319218 VISTA BRITE TIP GUIDING CATHETERS CARDIOLOGY GUIDING CATHETERS (DQY) DQY CORDIS DE MEXICO NA 16037907

    Patients

    Seq Age Sex Outcome Treatment
    1