BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH TEMPO AQUA 4F

    MDR report key: 2994216 · Received March 8, 2013

    Report

    Report Number
    9616099-2013-00134
    Event Type
    Injury
    Date Received
    March 8, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 12, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K000579
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER BECAME WEDGED THROUGH THE INTERSTICE OF A (NON-CORDIS) 4 X 38 MM. BALLOON EXPANDABLE STENT. THE CATHETER TRACKED OVER A (NON-CORDIS V18) GUIDEWIRE TO GET TO THIS POINT. WHEN THE PHYSICIAN TRIED TO RETRIEVE THE CATHETER HE MET RESISTANCE AT WHICH POINT THE TIP OF THE CATHETER BROKE OFF IN THE STRUT. THE TIP REMAINED IN THE PATIENT WHERE THEY LATER PUT IN ANOTHER BALLOON EXPANDABLE STENT TO JAIL IT OFF. THE TARGET LESION WAS BELOW THE KNEE AND WAS CALCIFIED. THERE WERE NO PRODUCT ISSUES OR CONTRIBUTING FACTORS REPORTED WITH THE GUIDEWIRE USED OR THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN WAS TRYING TO OBTAIN ACCESS TO THE DISTAL LESION WHEN THE EVENT OCCURRED. THERE WAS NO PRODUCT ISSUE NOTED UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU WITH NO PROBLEM NOTED. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE AND EXCESSIVE TORQUING WAS REQUIRED. THE DEVICE KINKED IN THE AREA OF THE SEPARATION. THE DEVICE SEPARATED APPROXIMATELY TWO (2) CM. FROM THE DISTAL END. THE PATIENT HAD A BELOW KNEE AMPUTATION PERFORMED WHICH WAS NOT RELATED TO THE REPORTED PRODUCT ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE. FAL: ONE NON STERILE UNIT OF 4F TEMPO AQUA 0.038" 125CM WAS RECEIVED COILED IN A PLASTIC BAG. SEPARATION NOTED AT INTERMEDIATE TIP AND BRITE TIP FUSION. SEPARATION END LOOKS ELONGATED AND EVIDENCE OF BRITE TIP REMAINS CAN BE OBSERVED ON THE INTERMEDIATE TIP. BRITE TIP WAS NOT INCLUDED WITH THE RETURNED DEVICE. ONE KINK WAS NOTED AT 116.6CM FROM THE STRAIN RELIEF. RESIDUES OF DRY BLOOD WERE NOTED IN THE SEPARATION AREA. NO OTHER ANOMALY WAS NOTED IN THE RETURNED DEVICE. SCANNING ELECTRON MICROSCOPE RESULTS SHOWED THAT THE TIP PRESENTED EVIDENCE OF ELONGATIONS; THIS CHARACTERISTIC SUGGESTS POSSIBLE STRETCHING/ PULLING UNTIL SEPARATION. CUTTING WAS DISCARDED AS A ROOT CAUSE SINCE NO CUTTING CHARACTERISTICS WERE OBSERVED IN THE BODY OF THE CATHETER. THE EXACT CAUSE OF THIS CONDITION COULD NOT BE CONCLUSIVELY DETERMINED. OUTER DIAMETER (OD) AND INNER DIAMETER (ID) OF THE RETURNED CATHETER WERE MEASURED NEAR TO SEPARATION SECTION AND KINKED AREA SECTION AND THREE DIFFERENT OD SECTIONS OF THE SHAFT WERE MEASURED AT PROXIMAL, MIDDLE AND DISTAL. ALL DIAMETER DIMENSIONS WERE FOUND WITHIN TOLERANCE. NO UNITS ARE AVAILABLE ON DISTRIBUTION CENTER ACCORDING TO JDE SYSTEM. PULL TEST WAS NOT PERFORMED SINCE NO STERILE UNITS WERE RETURNED FOR ANALYSIS. INSERTION AND WITHDRAWAL TEST WAS PERFORMED TO THE CATHETER UNIT USING A CSI 4FR AVANTI LAB. SAMPLE, NO RESISTANCE OR FRICTION WAS FELT DURING TEST. 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 REPORTED CUSTOMER COMPLAINT OF BRITE/TIP- DISTAL TIP SEPARATED WAS CONFIRMED THROUGH FAILURE ANALYSIS, WITHDRAWAL DIFFICULTY, HOWEVER; WAS NOT. REVIEW OF THE ANALYSIS AND THE EVENT DESCRIPTION SUGGESTS THAT LESION CHARACTERISTICS AND PROCEDURAL FACTORS (CATHETER JAILED BY THE INTERSTICES OF THE STENT) CONTRIBUTED TO THE REPORTED EVENT. 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.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION IS NOT COMPLETE. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE FIELD INDICATED THAT THE 4F TEMPO AQUA .038" 125CM VERT DIAGNOSTIC CATHETER BECAME WEDGED THRU THE INTERSTICE OF A (NON-CORDIS) 4 X 38 MM. BALLOON EXPANDABLE STENT. THE CATHETER TRACKED OVER A (NON-CORDIS V18) GUIDEWIRE TO GET TO THIS POINT. WHEN THE PHYSICIAN TRIED TO RETRIEVE THE CATHETER HE MET RESISTANCE AT WHICH POINT THE TIP OF THE CATHETER BROKE OFF IN THE STRUT. THE TIP REMAINED IN THE PATIENT WHERE THEY LATER PUT IN ANOTHER BALLOON EXPANDABLE STENT TO JAIL IT OFF. THE TARGET LESION WAS BELOW THE KNEE AND WAS CALCIFIED. THERE WERE NO PRODUCT ISSUES OR CONTRIBUTING FACTORS REPORTED WITH THE GUIDEWIRE USED OR THE PREVIOUSLY IMPLANTED STENT. THE PHYSICIAN WAS TRYING TO OBTAIN ACCESS TO THE DISTAL LESION WHEN THE EVENT OCCURRED. THERE WAS NO PRODUCT ISSUE NOTED UPON INSPECTION PRIOR TO USE. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE IFU WITH NO PROBLEM NOTED. THERE WAS RESISTANCE MET WHILE ADVANCING THE DEVICE AND EXCESSIVE TORQUING WAS REQUIRED. THE DEVICE KINKED IN THE AREA OF THE SEPARATION. THE DEVICE SEPARATED APPROXIMATELY TWO (2) CM. FROM THE DISTAL END. THE PATIENT HAD A BELOW KNEE AMPUTATION PERFORMED WHICH WAS NOT RELATED TO THE REPORTED PRODUCT ISSUE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    100292 CATH TEMPO AQUA 4F DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 15763422

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R XIENCE 4MM X 38MM STENT: V18 GUIDEWIRE