BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GC 5F 056 XB 3.5 LBT

    MDR report key: 13859770 · Received March 23, 2022

    Report

    Report Number
    9616099-2022-05478
    Event Type
    Malfunction
    Date Received
    March 23, 2022
    Date of Event
    February 25, 2022
    Report Date
    June 22, 2022
    Manufacturer
    CORDIS CORPORATION
    Product Code
    DQY
    UDI-DI
    20705032015223
    PMA / PMN Number
    K000715
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED AND THE PRODUCT MET QUALITY REQUIREMENTS FOR PRODUCT ACCEPTANCE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, DURING A CORONARY ANGIOPLASTY, A LONG BRITE TIP GUIDING CATHETER (GC 5F 056 XB 3.5 LBT) WAS REQUESTED BY THE HEMODYNAMICIST, AND ITS DISTAL TIP WAS OBSERVED SPLIT (TORN). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT USED AS THE DAMAGE WAS EVIDENT AT THE TIME OF OPENING THE PACKAGE. ANOTHER CATHETER WAS REQUESTED FROM THE PHARMACY AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A RADIAL APPROACH WAS USED. THE VESSEL HAD MILD TORTUOSITY AND NO STENOSIS. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18059962 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿BRITE TIP/DISTAL TIP - CATHETERS- FRAYED/SPLIT/TORN-DURING PREP¿ COULD NOT BE CONFIRMED. SHIPPING, STORAGE OR HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿INSPECT THE GUIDING CATHETER UPON REMOVAL FROM PACKAGING TO VERIFY THAT IT IS UNDAMAGED. WARNING: DO NOT USE A GUIDING CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH AN UNDAMAGED GUIDING CATHETER. ¿BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR ANALYSIS BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, DURING A CORONARY ANGIOPLASTY, A LONG BRITE TIP GUIDING CATHETER (GC 5F 056 XB 3.5 LBT) WAS REQUESTED BY THE HEMODYNAMICIST, AND ITS DISTAL TIP WAS OBSERVED SPLIT (TORN). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT USED AS THE DAMAGE WAS EVIDENT AT THE TIME OF OPENING THE PACKAGE. ANOTHER CATHETER WAS REQUESTED FROM THE PHARMACY AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A RADIAL APPROACH WAS USED. THE VESSEL HAD MILD TORTUOSITY AND NO STENOSIS. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. ONE NON-STERILE GC 5F 056 XB 3.5 LBT BRITE TIP GUIDING CATHETER WAS RECEIVED FOR ANALYSIS. PER VISUAL ANALYSIS, NO DAMAGES OR ANOMALIES WERE OBSERVED ON THE DISTAL TIP OR BODY SHAFT OF THE CATHETER. A PRODUCT HISTORY RECORD (PHR) REVIEW OF LOT 18059962 REVEALED NO ANOMALIES OR NON-CONFORMANCES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED EVENT. THE REPORTED FAILURE BY THE CUSTOMER, ¿BRITE TIP/DISTAL TIP - CATHETERS FRAYED/SPLIT/TORN-DURING PREP¿ WAS NOT CONFIRMED. THE RETURNED DEVICE DID NOT PRESENT WITH ANY DAMAGES. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿INSPECT THE GUIDING CATHETER UPON REMOVAL FROM PACKAGING TO VERIFY THAT IT IS UNDAMAGED. WARNING: DO NOT USE A GUIDING CATHETER THAT HAS BEEN DAMAGED IN ANY WAY. IF DAMAGE IS DETECTED, REPLACE WITH AN UNDAMAGED GUIDING CATHETER.¿ BASED ON THE INFORMATION AVAILABLE AND THE PHR REVIEW, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, DURING A CORONARY ANGIOPLASTY, A LONG BRITE TIP GUIDING CATHETER (GC 5F 056 XB 3.5 LBT) WAS REQUESTED BY THE HEMODYNAMICIST, AND ITS DISTAL TIP WAS OBSERVED SPLIT (TORN). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT USED AS THE DAMAGE WAS EVIDENT AT THE TIME OF OPENING THE PACKAGE. ANOTHER CATHETER WAS REQUESTED FROM THE PHARMACY AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A RADIAL APPROACH WAS USED. THE VESSEL HAD MILD TORTUOSITY AND NO STENOSIS. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED. THE DEVICE IS EXPECTED TO BE RETURN FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, DURING A CORONARY ANGIOPLASTY, A LONG BRITE TIP GUIDING CATHETER (GC 5F 056 XB 3.5 LBT) WAS REQUESTED BY THE HEMODYNAMICIST, AND ITS DISTAL TIP WAS OBSERVED SPLIT (TORN). THE DEVICE WAS NOT USED IN THE PATIENT. THERE WAS NO REPORTED PATIENT INJURY. THE CATHETER WAS NOT USED AS THE DAMAGE WAS EVIDENT AT THE TIME OF OPENING THE PACKAGE. ANOTHER CATHETER WAS REQUESTED FROM THE PHARMACY AND THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. A RADIAL APPROACH WAS USED. THE VESSEL HAD MILD TORTUOSITY AND NO STENOSIS. THE DEVICE WAS PROPERLY STORED AND OPENED IN STERILE FIELD. THE DEVICE WAS PREPPED PER THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO DIFFICULTY EXPERIENCED IN PREPPING THE DEVICE. NEITHER THE PRODUCT NOR ANY OF THE OTHER DEVICES USED WITH IT HAD BEEN RESTERILIZED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    265650 GC 5F 056 XB 3.5 LBT CATHETER, PERCUTANEOUS DQY CORDIS CORPORATION 5560540L 18059962 20705032015223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNK CATHETER.