BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATH 5F INFINITI TL JL3.5 100C

    MDR report key: 1983138 · Received February 10, 2011

    Report

    Report Number
    9616099-2011-00092
    Event Type
    Injury
    Date Received
    February 10, 2011
    Date of Event
    January 11, 2011
    Report Date
    January 17, 2011
    Manufacturer
    CORDIS DE MEXICO
    Product Code
    DQO
    PMA / PMN Number
    K970854
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS AVAILABLE FOR TESTING AND EVALUATION BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION RECEIVED WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT RECEIVED STATES THAT DURING USE A DIAGNOSTIC 5 F JL 3.5 CATHETER FRACTURED AND SEPARATED IN THE PATIENT. THE REPORT RECEIVED FROM THE AFFILIATE INDICATED A "DIAGNOSTIC CATHETER SPLIT INTO TWO PIECES DURING A PTCA PROCEDURE. A CARDIAC ECHOGRAPHY WAS NECESSARY TO FIND THE BROKEN PIECE. A 7F FEMORAL SHEATH HAD TO BE USED TO INTRODUCE A LOOP TO EXTRACT THIS PIECE FROM THE PATIENT DESPITE THE PROCEDURAL HAD BEEN RADIAL APPROACH." THE CATHETER SEPARATED AT THE DISTAL TIP AND IN THE BODY OF THE DEVICE. THE TARGET LESION WAS A 75% OCCLUDED LESION IN THE RCA WITH SEVERE VESSEL TORTUOUSITY. THE LESION WAS SEVERELY CALCIFIED WITH MODERATE ANGULATION. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS INITIALLY REMOVED FROM THE PACKAGE OR NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE AND HAD NOT BEEN RESTERILIZED. THE PRODUCT WAS RETURNED FOR ANALYSIS. (B)(4): ONE NON STERILE 5F DIAGNOSTIC CATHETER WAS RECEIVED COILED IN PLASTIC BAG. THE INTERMEDIATE TIP WAS FOUND SEPARATED. NO OTHER ANOMALIES WERE FOUND. ACCORDING TO THE SEM ANALYSIS, THE BODY AND THE TIP'S SURFACES DID NOT PRESENT EVIDENCE OF A WELL FORMED OR A PARTIAL FUSION. THE BODY SURFACE PRESENTED DAMAGE WHICH COULD BE CAUSED DURING THE BODY BACK-TAPPER PROCESS; HOWEVER THIS COULD NOT BE CONCLUSIVELY DETERMINED. THE OUTER AND INNER DIAMETER WAS MEASURED NEXT TO THE BODY-TIP SEPARATION AND WERE FOUND WITHIN DIMENSIONAL SPECIFICATION. NO UNITS LEFT IN FGI FROM THE COMPLAINT LOT OR BOUNDING LOTS AND NO CUSTOMER COMPLAINTS RELATED TO THE MANUFACTURING PROCESS WERE FOUND. 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. A MEETING WAS HELD WITH DX REPRESENTATIVES CONCLUDING THAT TIP SEPARATION SEEMS TO BE RELATED TO THE MANUFACTURING ST FUSING PROCESS SINCE THERE IS NO CLEAR EVIDENCE OF A FULL OR EVEN PARTIAL FUSING OR TRACES OF MATERIAL TRANSFER OBSERVED ON RETURNED UNIT. MALFUNCTION NOTIFICATION WAS SENT TO PRODUCT SAFETY DESIGNEE. THE TIP SEPARATION REPORTED BY THE CUSTOMER WAS CONFIRMED AND IT SEEMS TO BE RELATED TO THE MANUFACTURING FUSING PROCESS. ACTION TAKEN: (B)(4) WAS OPENED TO ADDRESS THIS TYPE OF FAILURE. FILM REVIEW: PER DR (B)(6): THE CASE IN CONTEXT INVOLVED A PATIENT WITH HEAVILY CALCIFIED CORONARY ARTERIES AND MASSIVE AORTO-ILIAC CALCIFICATIONS WITH ECTASIA AND TORTUOSITY. THE PATIENT UNDERWENT AN ATTEMPT AT INTERVENTION TO THE LEFT ANTERIOR DESCENDING AND A DIAGNOSTIC CATHETER ADVANCED AT THE END OF THE PROCEDURE WAS PLACED AND THE DISTAL SEGMENT WAS FRACTURED FROM THE BODY OF THE CATHETER. A SNARE WAS REQUIRED TO REMOVE THE FRAGMENT WITH NO APPARENT ADVERSE SEQUELAE. THE FINDINGS WERE EXTREMELY HEAVILY CALCIFIED AORTO-ILIAC SEGMENTS AND THE DIAGNOSTIC CATHETER THAT WAS PLACED AT THE END OF THE PROCEDURE WAS FRACTURED. IT IS NOT CLEAR TO ME WHETHER THIS IS A 5 OR 6 FRENCH CATHETER. IN THESE CASES WITH EXTREME CALCIFICATIONS AND TORTUOUSITY, THE USE OF A LONG SHEATH IS SOMETIMES HELPFUL AND EXCESSIVE CATHETER MANIPULATION MAY LEAD TO KINKING AND POSSIBLE FRACTURE OF THE CATHETER. IT APPEARS THAT THIS IS THE ETIOLOGY IN THIS CASE. THE COMPLAINT OF FRACTURED / SEPARATED WAS CONFIRMED ON ANALYSIS. FILM REVIEW SUGGESTS THAT BOTH VESSEL AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE CONFIRMED EVENT; HOWEVER, (B)(4) RELATES THE CONFIRMED FAILURE TO THE MANUFACTURING PROCESS. ACTION TAKEN: (B)(4) WAS OPENED TO ADDRESS THIS TYPE OF FAILURE.

    Description of Event or Problem · 1

    THE REPORT RECEIVED FROM THE AFFILIATE INDICATED A "DIAGNOSTIC CATHETER SPLIT INTO TWO PIECES DURING A PTCA PROCEDURE. A CARDIAC ECOGRAPHY WAS NECESSARY TO FIND THE BROKEN PIECE. A 7F FEMORAL SHEATH HAD TO BE USED TO INTRODUCE A LOOP TO EXTRACT THIS PIECE FROM THE PATIENT DESPITE THE PROCEDURE HAD BEEN PERFORMED BY RADIAL APPROACH." IT SEPARATED AT THE DISTAL TIP AND IN THE BODY OF THE DEVICE. THE TARGET LESION WAS A 75% OCCLUDED LESION IN THE RCA WITH SEVERE VESSEL TORTUOUSITY. THE LESION WAS SEVERELY CALCIFIED WITH MODERATE ANGULATION. NO ANOMALIES WERE NOTED WHEN THE DEVICE WAS INITIALLY REMOVED FROM THE PACKAGE OR NOTED DURING PREP. THE DEVICE WAS NOT INSERTED THROUGH A STOPCOCK INSTEAD OF A HEMOSTATIC VALVE AND HAD NOT BEEN RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH 5F INFINITI TL JL3.5 100C DIAGNOSTIC CARDIOLOGY CATHETER (DQO) DQO CORDIS DE MEXICO NA 15224016

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R