BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH 6F INFINI ANG PIG 110C 6S

    MDR report key: 2944460 · Received February 5, 2013

    Report

    Report Number
    9616099-2013-00046
    Event Type
    Malfunction
    Date Received
    February 5, 2013
    Date of Event
    January 10, 2013
    Report Date
    January 10, 2013
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED THAT WHEN THE PHYSICIAN PERFORMED A LEFT VENTRICULOGRAM USING MANUAL HAND INJECTION, AS OPPOSED TO POWER INJECTION, WITH A 6FR PIGTAIL CATHETER WITH SIDE HOLES, THE SIDE-HOLES DID NOT IRRIGATE SMOOTHLY/CONTRAST VISIBILITY WAS NOT GOOD. ANOTHER SIMILAR, SAME-TYPE CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. SIDE-HOLES WERE NOTED TO BE PRESENT. THERE WERE NO PARTIAL HOLES, MISSING HOLES, MISSHAPEN HOLES, OR MIS-LOCATED HOLES NOTED. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THE PRODUCT WAS FLUSHED PROPERLY WITH NO PROBLEMS NOTED DURING FLUSHING. THERE WAS NO REPORTED DIFFICULTY ADVANCING THE CATHETER OVER THE GUIDEWIRE USED. THE PRODUCT ISSUE WAS NOT THOUGHT TO BE DUE TO AN OBSTRUCTION. NO OTHER PRODUCT ISSUE WAS NOTED UPON INSPECTION POST-PROCEDURE OR PRIOR TO SHIPPING. THERE WAS NO REPORT OF PATIENT INJURY AND THE DEVICE WAS RETURNED FOR ANALYSIS. (B)(4): ONE NON STERILE UNIT OF CATH (B)(4) 110CM 6SH WAS RECEIVED COILED FOR ANALYSIS. COMPRESSED CONDITIONS WERE NOTED ON THE BODY/SHAFT AT 7.5CM, 14CM, 51CM AND 75CM FROM HUB. THE 6 HOLES LOOKS IN GOOD CONDITIONS, DRY BLOOD RESIDUALS WERE FOUND ON THE DISTAL SECTION. NO OTHER ANOMALY WAS OBSERVED. THE SIDE HOLES AREA WAS INSPECTED UNDER SYSTEM VISION AND THE HOLES LOOKS IN GOOD CONDITIONS. A LAB SAMPLE SYRINGE WITH WATER WAS ATTACHED TO THE CATHETER AND IT WAS FLUSHED SUCCESSFULLY (THE WATER CAME OUT THROUGH THE HOLES), A 0.038 EMERALD GUIDEWIRE LAB SAMPLE WAS INSERTED IN THE RECEIVED CATHETER AND IT WENT THROUGH WITH SOME SLIGHT FRICTION FELT WHEN THE GUIDEWIRE WAS PASSED IN THE COMPRESSED AREA OF THE CATHETER. RESISTANCE WAS NOT FELT IN THE REST OF THE CATHETER. AS ADDITIONAL INVESTIGATION THE DIAGNOSTIC CATHETER MANUFACTURING PROCESS WAS REVIEWED AND THERE WERE NO TOOLS, EQUIPMENT OR PRODUCT HANDLING THAT COULD CAUSE COMPRESS OR OTHER TYPE OF DAMAGE ON THE CATHETERS. THE REPORTED CUSTOMER COMPLAINT OF NO SIDE HOLES WAS NOT CONFIRMED THROUGH FAILURE ANALYSIS. THE PERFORMANCE OF A MANUAL HAND INJECTION FOR A LEFT VENTRICULOGRAM IS RESERVED FOR MULTIPURPOSE CATHETERS WITHOUT SIDE HOLES. THE PIGTAIL CATHETERS WITH SIDE HOLES REQUIRE MUCH MORE FORCE TO EFFECTIVELY INJECT THE CONTRAST AND PROVIDE GOOD VISUALIZATION, THUS ARE TYPICALLY RESERVED FOR USE WITH A POWER INJECTOR. REVIEW OF THE INFORMATION PROVIDED SUGGESTS THAT USER HANDLING MAY HAVE CONTRIBUTED TO THE REPORTED EVENT, THERE IS NOTHING IN THE ANALYSIS, THE DEVICE HISTORY REPORT REVIEW OR THE EVENT DESCRIPTION TO SUGGEST THAT THERE IS A DESIGN OR MANUFACTURING RELATED ISSUE THEREFORE NO CORRECTIVE ACTIONS 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 AFFILIATE INDICATED THAT WHEN THE PHYSICIAN FLUSHED/DID A HAND-INJECTION USING THE CATH F6INF PIG 145 110CM 6SH DIAGNOSTIC PIGTAIL CATHETER (WITH CONTRAST), THE SIDE-HOLES DID NOT IRRIGATE SMOOTHLY/CONTRAST VISIBILITY WAS NOT GOOD. ANOTHER SIMILAR, SAME-TYPE CATHETER WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THERE WAS NO REPORTED PATIENT INJURY. THE PRODUCT WAS INSPECTED PRIOR TO USE AND APPEARED TO BE NORMAL. SIDE-HOLES WERE NOTED TO BE PRESENT. THERE WERE NO PARTIAL HOLES, MISSING HOLES, MIS-SHAPED HOLES, OR MIS-LOCATED HOLES NOTED. THE PRODUCT WAS PREPPED PROPERLY ACCORDING TO THE INSTRUCTIONS FOR USE (IFU) WITH NO PROBLEMS NOTED. THE PRODUCT WAS FLUSHED PROPERLY WITH NO PROBLEMS NOTED DURING FLUSHING. THERE WAS NO REPORTED DIFFICULTY ADVANCING THE CATHETER OVER THE GUIDEWIRE USED. THE PRODUCT ISSUE WAS NOT THOUGHT TO BE DUE TO AN OBSTRUCTION. NO OTHER PRODUCT ISSUE WAS NOTED UPON INSPECTION POST-PROCEDURE OR PRIOR TO SHIPPING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48599 CATH 6F INFINI ANG PIG 110C 6S DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15227834

    Patients

    Seq Age Sex Outcome Treatment
    1