BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 3-LUMEN 7FR X 16CM

    MDR report key: 4913319 · Received July 14, 2015

    Report

    Report Number
    3006425876-2015-00231
    Event Type
    Injury
    Date Received
    July 14, 2015
    Date of Event
    July 6, 2015
    Report Date
    July 10, 2015
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CI
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED COMPLAINT WAS CONFIRMED THROUGH EXAMINATION OF A RETURNED PRODUCT SAMPLE AND PHOTOGRAPHS PROVIDED BY THE CUSTOMER. THE CUSTOMER PROVIDED A GUIDE WIRE AND 3-LUMEN CATHETER. THE CUSTOMER ALSO PROVIDED PHOTOGRAPHS OF AN X-RAY OF THE PATIENT CONTAINING THE DISTAL PIECE OF THE GUIDE WIRE THAT HAD BROKEN OFF. THE RETURNED GUIDE WIRE WAS KINKED NEAR THE DISTAL END AND THE J-TIP PORTION HAD BEEN SEPARATED AND NOT RETURNED. MICROSCOPIC EXAMINATION OF THE BROKEN END REVEALED THAT THE CORE AND COIL WIRES WERE FLAT INDICATING THEY HAD FRACTURED UNDER APPLIED FORCE. BASED ON THE NOMINAL LENGTH IN THE GRAPHIC, APPROXIMATELY 3 CM OF THE DISTAL END WERE MISSING. THE REMAINING PIECE OF GUIDE WIRE WAS INSERTED THROUGH THE RETURNED CATHETER WITHOUT RESISTANCE UNTIL THE KINK ENTERED THE TIP. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. BASED ON THE CHARACTERISTICS OF THE DAMAGE TO THE GUIDE WIRE AND THE INFORMATION REPORTED, OPERATIONAL CONTEXT CAUSED OR CONTRIBUTED TO THIS EVENT. NO FURTHER ACTION WILL BE TAKEN.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION: THIS PRODUCT IS NOT SOLD IN THE US. THE 510K NUMBER PROVIDED IS FOR A SIMILAR PRODUCT THAT IS SOLD IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT IN THE ICU, THE INSERTION WAS PERFORMED ON THE FIRST PUNCTURE, WITHOUT DIFFICULTY TO PASS THE GUIDE WIRE AND DILATOR INTO THE PATIENT'S RIGHT SUBCLAVIAN. HOWEVER, WHEN TRYING TO PASS THE CATHETER OVER THE GUIDE WIRE, THE CATHETER COULD NOT BE ADVANCED WHICH PROMPTED THE DECISION TO REMOVE BOTH THE CATHETER AND GUIDE WIRE TOGETHER. DURING THAT REMOVAL, THE GUIDE WIRE UNRAVELED AND THE J-TIP BROKE OFF AND REMAINED BETWEEN THE VEIN AND THE SKIN IN THE PATIENT'S TORSO. X-RAYS WERE TAKEN SHOWING THE RETAINED GUIDE WIRE IN THE PATIENT'S TORSO AND AS A RESULT, THE PATIENT WAS TAKEN TO THE CATH LAB WERE THE RETAINED PIECE WAS SUCCESSFULLY REMOVED BY A VASCULAR SURGEON. THERE WAS NO REPORTED DELAY, DEATH, OR ADDITIONAL COMPLICATIONS TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456486 CVC SET: 3-LUMEN 7FR X 16CM ARROWG+ARD CATHETER PRODUCTS FOZ ARROW INTERNATIONAL INC. 71F14F1467

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention