BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH TEMPO 5

    MDR report key: 3792721 · Received May 6, 2014

    Report

    Report Number
    9616099-2014-00302
    Event Type
    Malfunction
    Date Received
    May 6, 2014
    Date of Event
    April 11, 2014
    Report Date
    April 14, 2014
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THAT WITHIN THE NON-CORDIS GUIDE CATHETER IN THE PATIENT, THE 5F CATH TEMPO H1 COULD NOT BE SUCCESSFULLY FLUSHED. THE GUIDE CATHETER WAS ¿BLOCKED.¿ THE CATHETER WAS REMOVED AND THE PHYSICIAN NOTED A ¿BLUE COLLAR¿ THERE WAS NO PATIENT INJURY. FOLLOWING THE FLUSHING DIFFICULTY, THE PHYSICIAN FELT THE BLOCKAGE MAY BE CAUSED BY A CLOT, REMOVED THE CATHETER, THEN REINSERTED IT BACK INTO THE PATIENT WHERE HE ATTEMPTED TO FLUSH AGAIN AND WAS UNSUCCESSFUL. HE THEN REMOVED BOTH THE TEMPO AND THE GUIDE CATHETER. UPON DISMANTLING THE HUB ON THE GUIDE CATHETER, HE SAW A BLUE COLLAR ¿EXACTLY LIKE THE COLLAR ON THE CATH TEMPO.¿ IT WAS ASSUMED THAT THE TEMPO CATHETER HAD A SECOND COLLAR WHICH CAME OFF AND ¿WAS CLOSE TO BEING INJECTED INTO THE PATIENT¿. THE CATHETER WAS EXCHANGED FOR ANOTHER TO CONTINUE THE CASE. THERE WERE NO ANOMALIES NOTED WHEN THE CATH TEMPO WAS REMOVED FROM ITS PACKAGING. THE CATH TEMPO WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). NO ANOMALIES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. NO KINKS WERE NOTED ON EITHER THE TEMPO CATHETER OR THE GUIDE CATHETER. A NON-STERILE DIAGNOSTIC CATHETER CATH TEMPO 5F H1 100CM WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG ALONG WITH A LOOSE PIECE OF MATERIAL APPEARING TO BE A STRAIN RELIEF COMPONENT (WHICH DOES NOT SEEM TO BELONG TO THE RECEIVED TEMPO CATHETER). PER VISUAL ANALYSIS, THE RECEIVED TEMPO CATHETER WAS THOROUGHLY INSPECTED AND ITS STRAIN RELIEF WAS FOUND PROPERLY AFFIXED TO THE HUB AND BODY SHAFT AT THE PROXIMAL PART OF THE CATHETER. TWO KINKS WERE FOUND ON THE BODY SHAFT OF THE TEMPO CATHETER AT 60.0 CM AND AT 76.0 CM FROM THE HUB. APART FROM THE KINKS FOUND, NO OTHER ANOMALIES WERE OBSERVED ON THE TEMPO CATHETER UNIT. 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 RECEIVED TEMPO DIAGNOSTIC CATHETER OD AND ID WERE MEASURED NEAR TO THE KINKS FOUND AND RESULTS WERE FOUND WITHIN SPECIFICATION. THE RECEIVED LOOSE PIECE OF MATERIAL APPEARING TO BE A STRAIN RELIEF COMPONENT (WHICH IS NOT PART OF THE TEMPO COMPLAINT¿S CATHETER) WAS VISUALLY AND DIMENSIONALLY INSPECTED. THE DIMENSIONS OF THE LOOSE STRAIN RELIEF COINCIDED WITH THOSE OF THE STRAIN RELIEF PART NUMBER 01A3771. A LAB SAMPLE SYRINGE FILLED WITH WATER WAS ATTACHED TO THE HUB OF THE DIAGNOSTIC TEMPO CATHETER AND SUCCESSFULLY FLUSHED. NEITHER OBSTRUCTION NOR LOOSEN MATERIAL/ MATTER WAS OBSERVED DURING FLUSHING. THEN, A CORDIS LAB SAMPLE EMERALD GUIDE WIRE.038¿ 150 CM (502-588) WAS INTRODUCED VIA HUB INTO THE CATHETER AND IN SPITE OF KINKS FOUND, THE WIRE SUCCESSFULLY PASSED THROUGH THE CATHETER. THERE WAS NO RESISTANCE EXPERIENCED DURING GUIDE WIRE INSERTION OR DURING WITHDRAWAL TESTS PERFORMED. ALSO, THE LOOSE PIECE OF THE STRAIN RELIEF COMPONENT RECEIVED WAS INSERTED OVER THE TEMPO CATHETER¿S DISTAL TIP AND SUCCESSFULLY PASSED OVER THE CATHETER LENGTH UP TO THE EXISTENT TEMPO¿S STRAIN RELIEF. MICROSCOPIC ANALYSIS TO INSPECT THE UNIT UNDER X-RAY DEVICE WAS NOT PERFORMED SINCE NEITHER OBSTRUCTION NOR SEPARATION WAS CONFIRMED ON THE UNIT. NEITHER THE REPORTED ¿DIAGNOSTIC ENDOVASCULAR CATHETERS-CATHETER (BODY/SHAFT) - OBSTRUCTED¿ NOR THE ¿DIAGNOSTIC ENDOVASCULAR CATHETERS-CATHETER (BODY/SHAFT) - SEPARATED¿ FAILURES WERE CONFIRMED. VISUAL, DIMENSIONAL AND FUNCTIONAL ANALYSIS WERE SUCCESSFULLY PERFORMED AND BESIDES THE KINKS FOUND NO OTHER ANOMALIES WERE OBSERVED ON THE RECEIVED TEMPO CATHETER. THE LOOSE PIECE OF STRAIN RELIEF COMPONENT FOUND BY THE REPORTER WAS CONFIRMED TO BE A STRAIN RELIEF COMPONENT (NOT PART OF THE TEMPO CATHETER RECEIVED). PER DIMENSIONAL AND FUNCTIONAL ANALYSIS RESULTS, THIS COMPLAINT HAS BEEN DETERMINED TO BE A MANUFACTURING-RELATED ISSUE AND A RISK ASSESSMENT HAS BEEN INITIATED TO INVESTIGATE THIS ISSUE. THE REPORTED COMPLAINT ¿CATHETER/BODY SHAFT-SEPARATED¿ AND ¿CATHETER/BODY SHAFT OBSTRUCTED¿ WAS NOT CONFIRMED THROUGH ANALYSIS AS THE DEVICE PERFORMED AS INTENDED DURING FUNCTIONAL ANALYSIS. HOWEVER, HOWEVER, A LOOSE PIECE OF STRAIN RELIEF COMPONENT WAS FOUND BY THE REPORTER AND RETURNED WITH THE TEMPO CATHETER. IT WAS DETERMINED BY ANALYSIS THAT THE STRAIN RELIEF RETURNED WAS NOT PART OF THE TEMPO CATHETER RECEIVED, BUT MAY HAVE BEEN RELATED TO THE MANUFACTURING PROCESS. A RISK ASSESSMENT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE.

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLIANT CONCLUSION UPDATED TO INCLUDE UPDATED ANALYSIS. DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THAT WITHIN THE NON-CORDIS GUIDE CATHETER IN THE PATIENT, THE 5F CATH TEMPO H1 COULD NOT BE SUCCESSFULLY FLUSHED. THE GUIDE CATHETER WAS ¿BLOCKED¿. THE CATHETER WAS REMOVED AND THE PHYSICIAN NOTED A ¿BLUE COLLAR¿ THERE WAS NO PATIENT INJURY. FOLLOWING THE FLUSHING DIFFICULTY, THE PHYSICIAN FELT THE BLOCKAGE MAY BE CAUSED BY A CLOT, REMOVED THE CATHETER, THEN REINSERTED IT BACK INTO THE PATIENT WHERE HE ATTEMPTED TO FLUSH AGAIN AND WAS UNSUCCESSFUL. HE THEN REMOVED BOTH THE TEMPO AND THE GUIDE CATHETER. UPON DISMANTLING THE HUB ON THE GUIDE CATHETER, HE SAW A BLUE COLLAR ¿EXACTLY LIKE THE COLLAR ON THE CATH TEMPO¿. IT WAS ASSUMED THAT THE TEMPO CATHETER HAD A SECOND COLLAR WHICH CAME OFF AND ¿WAS CLOSE TO BEING INJECTED INTO THE PATIENT¿. THE CATHETER WAS EXCHANGED FOR ANOTHER TO CONTINUE THE CASE. THERE WERE NO ANOMALIES NOTED WHEN THE CATH TEMPO WAS REMOVED FROM ITS PACKAGING. THE CATH TEMPO WAS PREPPED PER INSTRUCTIONS FOR USE (IFU). NO ANOMALIES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. NO KINKS WERE NOTED ON EITHER THE TEMPO CATHETER OR THE GUIDE CATHETER. A NON STERILE DIAGNOSTIC CATHETER CATH TEMPO 5F H1 100CM WAS RECEIVED FOR ANALYSIS COILED INSIDE A PLASTIC BAG ALONG WITH A LOOSE PIECE OF MATERIAL APPEARING TO BE A STRAIN RELIEF COMPONENT (WHICH IS NOT PART OF THE RECEIVED TEMPO CATHETER). PER VISUAL ANALYSIS, THE RECEIVED TEMPO CATHETER WAS THOROUGHLY INSPECTED AND ITS STRAIN RELIEF WAS OBSERVED PROPERLY AFFIXED TO THE HUB AND BODY SHAFT AT PROXIMAL PART OF CATHETER. TWO KINKS WERE FOUND ON BODY SHAFT OF TEMPO CATHETER AT 60.0 CM AND AT 76.0 CM FROM HUB. BESIDES THE KINKS FOUND, NO OTHER ANOMALIES WERE OBSERVED ON THE TEMPO CATHETER UNIT. THE RECEIVED TEMPO DIAGNOSTIC CATHETER OD AND ID WERE MEASURED NEAR TO THE FOUND KINKS AGAINST DRAWING AND RESULTS WERE FOUND WITHIN SPECIFICATION. ALSO, THE RECEIVED SPARE LOOSE PIECE OF MATERIAL (WHICH IS NOT PART OF THE TEMPO COMPLAINT¿S CATHETER) WAS VISUALLY AND DIMENSIONALLY INSPECTED, SINCE IT WAS PREVIOUSLY REFERRED TO IN THE COMPLAINT EVENT DESCRIPTION AS A PIECE OF STRAIN RELIEF COMPONENT. THE DIMENSIONS OF THE LOOSE STRAIN RELIEF COINCIDED WITH THOSE OF THE STRAIN RELIEF PART NUMBER 01A3771. MICROSCOPIC ANALYSIS TO MAGNIFY PHOTOS OF FOREIGN MATERIAL WAS NOT PERFORMED DUE TO THE LOOSE PIECE OF MATERIAL RECEIVED WAS IDENTIFIED AS A STRAIN RELIEF COMPONENT (WHICH IS NOT PART OF THE RECEIVED TEMPO CATHETER). 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. ANALYSIS OF THE RETURNED DEVICE NOTED A LOOSE PIECE OF STAIN RELIEF THUS CONFIRMING THE PRESENCE OF ¿FOREIGN MATERIAL.¿ IT WAS DETERMINED BY ANALYSIS THAT THE STRAIN RELIEF RETURNED WAS NOT PART OF THE TEMPO CATHETER RECEIVED, BUT MAY HAVE BEEN RELATED TO THE MANUFACTURING PROCESS. A RISK ASSESSMENT HAS BEEN INITIATED TO INVESTIGATE THE ISSUE.

    Description of Event or Problem · 1

    DURING AN UNKNOWN PROCEDURE, IT WAS REPORTED THAT THE PHYSICIAN HAD THE 5F CATH TEMPO H1 IN THE GUIDE CATHETER (PENUMBRA NEUROMAX) AND INJECTED FLUSH DOWN INTO THE PATIENT BUT THE GUIDE CATHETER BLOCKED. THE PHYSICIAN THINKING IT WAS CLOTTED STOPPED INJECTING AND PULLED THE CATH TEMPO OUT AND PUT IT BACK IN. TRIED INJECTING AGAIN BUT STILL NOT WORKING AND REMOVED BOTH THE CATH TEMPO AND THE GUIDE CATHETER. DISMANTLED THE HUB ON THE GUIDE CATHETER AND THERE WAS A BLUE COLLAR IN THE GUIDE CATHETER. IT IS EXACTLY THE SAME AS THE COLLAR ON THE CATH TEMPO SO HE COULD ONLY ASSUME THAT THE CATH TEMPO HAD A SECOND COLLAR WHICH CAME OFF AND WAS CLOSE TO BEING INJECTED INTO THE PATIENT. THEY CHANGED EVERYTHING AND CONTINUED THE CASE WITH ANOTHER CATHETER. NO PATIENT INJURY REPORTED. NO ANOMALIES WERE NOTED WHEN THE CATH TEMPO WAS REMOVED FROM ITS PACKAGING. THE CATH TEMPO WAS PREPPED PER IFU INSTRUCTIONS. NO ANOMALIES WERE NOTED PRIOR TO INSERTING THE PRODUCT INTO THE PATIENT. NO KINKS WERE NOTED ON EITHER THE CATH TEMPO OR THE GUIDE CATHETER. NO PICTURES ARE AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270350 CATH TEMPO 5 DIAGNOSTIC ENDOVASCULAR CATHETERS (DQO) DQO CORDIS DE MEXICO NA 15998231

    Patients

    Seq Age Sex Outcome Treatment
    1