BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CROSSER CATHETER 14S

    MDR report key: 6444861 · Received March 29, 2017

    Report

    Report Number
    2020394-2017-00262
    Event Type
    Malfunction
    Date Received
    March 29, 2017
    Date of Event
    December 10, 2014
    Report Date
    March 30, 2017
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    PDU
    UDI-DI
    10801741125420
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. ABSTRACT BOOK REVIEW: BETWEEN SEPTEMBER 2014 AND JULY 2015, 81 CRITICAL LIMB ISCHEMIA (CLI) PATIENTS WERE TREATED WITH CROSSER. SUCCESSFUL RECANALIZATION WAS OBTAINED IN 94 CASES (92%). THERE WERE THREE CASES OF TIP OR CORE WIRE SEPARATION OF THE CROSSER CATHETER AND 2 CASES OF GUIDEWIRE BREAKAGE. IN THREE CASES THE TIP AND WIRE FRAGMENTS WERE RETRIEVED RETROGRADE FROM THE GROIN BY A SNARE, IN ONE CASE, THE TIP WAS RETRIEVED ANTEGRADE, AND IN THE LAST CASE, THE TIP RETRIEVAL WAS ABANDONED AS IT WAS LOCATED IN A FAR DISTAL POSITION SATO, T. (2016). USEFULNESS AND COMPLICATIONS OF THE CROSSER SYSTEM IN HEAVILY CALCIFIED BELOW-THE-KNEE ARTERIES OF HEMODIALYSIS PATIENTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 39 (SUPPLEMENT 3), S302. DOI: 10.1007/S00270-016-1405-3 IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED. THE DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS AND PRECAUTIONS: WHEN USING THE CROSSER® CATHETER IN TORTUOUS ANATOMY, THE USE OF A SUPPORT CATHETER IS RECOMMENDED TO PREVENT KINKING OR PROLAPSE OF THE CROSSER® CATHETER TIP. KINKING OR PROLAPSE OF THE TIP COULD CAUSE CATHETER BREAKAGE AND/OR MALFUNCTION. DO NOT EXCEED 5 MINUTES OF ACTIVATION TIME AS CROSSER CATHETER MALFUNCTION MAY OCCUR. IF 5 MINUTES OF ACTIVATION TIME IS ACHIEVED EXCHANGE FOR A SECOND CROSSER CATHETER BEFORE RESETTING THE CROSSER GENERATOR ADVERSE EVENTS: AS WITH MOST PERCUTANEOUS INTERVENTIONS, POTENTIAL ADVERSE EFFECTS INCLUDE: BLEEDING WHICH MAY REQUIRE TRANSFUSION OR SURGICAL INTERVENTION, HEMATOMA, PERFORATION, DISSECTION, GUIDEWIRE ENTRAPMENT AND/OR FRACTURE, HYPERTENSION/HYPOTENSION, INFECTION OR FEVER, ALLERGIC REACTION, PSEUDOANEURYSM OR FISTULA ANEURYSM, ACUTE RECLOSURE, THROMBOSIS, ISCHEMIC EVENTS, DISTAL EMBOLIZATION, EXCESSIVE CONTRAST LOAD RESULTING IN RENAL INSUFFICIENCY OR FAILURE, EXCESSIVE EXPOSURE TO RADIATION, STROKE/CVA, RESTENOSIS, REPEAT CATHETERIZATION / ANGIOPLASTY, PERIPHERAL ARTERY BYPASS, AMPUTATION, DEATH OR OTHER BLEEDING COMPLICATIONS AT ACCESS SITE. SET UP: BACK THE RIGID PORTION OF THE CATHETER OUT OF THE END OF THE HOOP, THEN CAREFULLY UNSNAP THE CATHETER FROM THE HOOP WITH A GENTLE TWISTING MOTION. SET THE IRRIGATION SYSTEM TO 0.3ML/SEC (18ML/MIN) AND SWITCH IRRIGATION SYSTEM "ON". ALLOW IRRIGATION TO FLOW FOR APPROXIMATELY 10-15 SECONDS TO PURGE ALL AIR FROM THE CROSSER CATHETER IRRIGATION LUMEN. INTERVENTIONAL USE: SLOWLY ADVANCE THE CATHETER TIP THROUGH THE LESION. APPLY STEADY, CONSTANT PRESSURE SO THE TIP OF THE CATHETER IS ENGAGED TO THE LESION. UPON SUCCESSFUL RECANALIZATION OF THE LESION, ADVANCE THE GUIDEWIRE DISTAL TO THE LESION AND THEN WITHDRAW THE CROSSER 14S CATHETER. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Additional Manufacturer Narrative · 1

    MANUFACTURING REVIEW: AS THE LOT NUMBER FOR THE DEVICE WAS NOT PROVIDED, A MANUFACTURING REVIEW COULD NOT BE PERFORMED. VISUAL/MICROSCOPIC INSPECTION: AS THE DEVICE WAS NOT RETURNED, AN INSPECTION COULD NOT BE PERFORMED. FUNCTIONAL/PERFORMANCE EVALUATION: AS THE DEVICE WAS NOT RETURNED, AN EVALUATION COULD NOT BE PERFORMED. MEDICAL RECORDS REVIEW: AS MEDICAL RECORDS WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. ABSTRACT BOOK REVIEW: BETWEEN SEPTEMBER 2014 AND JULY 2015, 81 CRITICAL LIMB ISCHEMIA (CLI) PATIENTS WERE TREATED WITH CROSSER. SUCCESSFUL RECANALIZATION WAS OBTAINED IN 94 CASES (92%). THERE WERE THREE CASES OF TIP OR CORE WIRE SEPARATION OF THE CROSSER CATHETER AND 2 CASES OF GUIDEWIRE BREAKAGE. IN THREE CASES THE TIP AND WIRE FRAGMENTS WERE RETRIEVED RETROGRADE FROM THE GROIN BY A SNARE, IN ONE CASE, THE TIP WAS RETRIEVED ANTEGRADE, AND IN THE LAST CASE, THE TIP RETRIEVAL WAS ABANDONED AS IT WAS LOCATED IN A FAR DISTAL POSITION SATO, T. (2016). USEFULNESS AND COMPLICATIONS OF THE CROSSER SYSTEM IN HEAVILY CALCIFIED BELOW-THE-KNEE ARTERIES OF HEMODIALYSIS PATIENTS. CARDIOVASCULAR AND INTERVENTIONAL RADIOLOGY, 39 (SUPPLEMENT 3), S302. IMAGE/PHOTO REVIEW: AS MEDICAL IMAGES WERE NOT PROVIDED, A REVIEW COULD NOT BE PERFORMED. CONCLUSION: THE INVESTIGATION IS INCONCLUSIVE AS THE DEVICE WAS NOT RETURNED. THE DEFINITIVE ROOT CAUSE FOR THIS EVENT COULD NOT BE DETERMINED BASED UPON THE AVAILABLE INFORMATION. IT IS UNKNOWN WHETHER PATIENT AND/OR PROCEDURAL ISSUES CONTRIBUTED TO THE EVENT. LABELING REVIEW: THE CURRENT IFU (INSTRUCTIONS FOR USE) STATES: WARNINGS AND PRECAUTIONS: WHEN USING THE CROSSER® CATHETER IN TORTUOUS ANATOMY, THE USE OF A SUPPORT CATHETER IS RECOMMENDED TO PREVENT KINKING OR PROLAPSE OF THE CROSSER® CATHETER TIP. KINKING OR PROLAPSE OF THE TIP COULD CAUSE CATHETER BREAKAGE AND/OR MALFUNCTION. DO NOT EXCEED 5 MINUTES OF ACTIVATION TIME AS CROSSER CATHETER MALFUNCTION MAY OCCUR. IF 5 MINUTES OF ACTIVATION TIME IS ACHIEVED EXCHANGE FOR A SECOND CROSSER CATHETER BEFORE RESETTING THE CROSSER GENERATOR ADVERSE EVENTS: AS WITH MOST PERCUTANEOUS INTERVENTIONS, POTENTIAL ADVERSE EFFECTS INCLUDE: BLEEDING WHICH MAY REQUIRE TRANSFUSION OR SURGICAL INTERVENTION, HEMATOMA, PERFORATION, DISSECTION, GUIDEWIRE ENTRAPMENT AND/OR FRACTURE, HYPERTENSION/HYPOTENSION, INFECTION OR FEVER, ALLERGIC REACTION, PSEUDOANEURYSM OR FISTULA ANEURYSM, ACUTE RECLOSURE, THROMBOSIS, ISCHEMIC EVENTS, DISTAL EMBOLIZATION, EXCESSIVE CONTRAST LOAD RESULTING IN RENAL INSUFFICIENCY OR FAILURE, EXCESSIVE EXPOSURE TO RADIATION, STROKE/CVA, RESTENOSIS, REPEAT CATHETERIZATION / ANGIOPLASTY, PERIPHERAL ARTERY BYPASS, AMPUTATION, DEATH OR OTHER BLEEDING COMPLICATIONS AT ACCESS SITE. SET UP: BACK THE RIGID PORTION OF THE CATHETER OUT OF THE END OF THE HOOP, THEN CAREFULLY UNSNAP THE CATHETER FROM THE HOOP WITH A GENTLE TWISTING MOTION. SET THE IRRIGATION SYSTEM TO 0.3ML/SEC (18ML/MIN) AND SWITCH IRRIGATION SYSTEM "ON." ALLOW IRRIGATION TO FLOW FOR APPROXIMATELY 10-15 SECONDS TO PURGE ALL AIR FROM THE CROSSER CATHETER IRRIGATION LUMEN. INTERVENTIONAL USE: SLOWLY ADVANCE THE CATHETER TIP THROUGH THE LESION. APPLY STEADY, CONSTANT PRESSURE SO THE TIP OF THE CATHETER IS ENGAGED TO THE LESION. UPON SUCCESSFUL RECANALIZATION OF THE LESION, ADVANCE THE GUIDEWIRE DISTAL TO THE LESION AND THEN WITHDRAW THE CROSSER 14S CATHETER. THE INFORMATION PROVIDED BY BARD REPRESENTS ALL OF THE KNOWN INFORMATION AT THIS TIME. DESPITE GOOD FAITH EFFORTS TO OBTAIN ADDITIONAL INFORMATION, THE COMPLAINANT / REPORTER WAS UNABLE OR UNWILLING TO PROVIDE ANY FURTHER PATIENT, PRODUCT, OR PROCEDURAL DETAILS TO BARD.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TREATMENT OF A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY, THE DISTAL TIP OF A RECANALIZATION CATHETER ALLEGEDLY DETACHED. THE DETACHED TIP WAS SUCCESSFULLY REMOVED WITH THE USE OF A SNARE DEVICE. NO ADDITIONAL INTERVENTION WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING TREATMENT OF A HEAVILY CALCIFIED LESION IN THE ANTERIOR TIBIAL ARTERY, THE DISTAL TIP OF A RECANALIZATION CATHETER ALLEGEDLY DETACHED. THE DETACHED TIP WAS SUCCESSFULLY REMOVED WITH THE USE OF A SNARE DEVICE. NO ADDITIONAL INTERVENTION WAS NEEDED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226394 CROSSER CATHETER 14S RECANALIZATION CATHETER PDU BARD PERIPHERAL VASCULAR, INC. UNKNOWN 10801741125420

    Patients

    Seq Age Sex Outcome Treatment
    1