BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CATH PKGD: WEDGE 5 FR 110CM

    MDR report key: 22749666 · Received August 8, 2025

    Report

    Report Number
    3010532612-2025-00736
    Event Type
    Malfunction
    Date Received
    August 8, 2025
    Date of Event
    July 11, 2025
    Report Date
    July 14, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYG
    UDI-DI
    00801902002853
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    QN# (B)(4). RETURNED FOR INVESTIGATION WAS A 5FR. WEDGE 110CM CATHETER WITH THE ORIGINAL PACKAGING. THE SAMPLE WAS RETURNED IN THE UPS SHIPPING BOX AND WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING POUCH. UPON RETURN, THE SUPPLIED CONTROL STROKE SYRINGE WAS CONNECTED TO THE INFLATION LUMEN STOP-COCK; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED SYRINGE. THE INFLATION LUMEN STOPCOCK WAS NOTED IN THE OPEN POSITION. THE RECOMMENDED VOLUME CAPACITY OF THE BALLOON IS 0.75CC. UPON MICROSCOPIC INSPECTION, THE BALLOON APPEARED TYPICAL. NO CONDENSATION WAS NOTED IN THE INFLATION LUMEN EXTENSION LINE. NO CONTRAST MEDIA OR BLOOD WAS NOTED WITHIN INJECTION LUMEN EXTENSION LINE. UP-ON FURTHER INSPECTION, THE INJECTION LUMEN EXTENSION LINE LUER WAS FOUND TO BE DAMAGED; THE DAMAGE IS CONSISTENT WITH A CRACK. THE TOTAL LENGTH OF THE CRACK IS APPROXIMATELY 1.1CM. DRIED BLOOD WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. SOME DRIED BLOOD WAS ALSO NOTED WITHIN THE DISTAL OPENING OF THE INJECTION LUMEN. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY. ONE SIDE OF THE BALLOON MEASURED APPROXIMATELY 4MM. THE OTHER SIDE MEASURED APPROXIMATELY 4MM. THE BALLOON DID MEET SPECIFICATIONS PER GRAPHIC OF RADIUS RATIO LESS THAN OR EQUAL TO 2.0. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY. THE BALLOON DEFLATED IN LESS THAN 3 SECONDS WHEN THE SYRINGE WAS REMOVED PER SPECIFICATION. NO PULL AWAY WAS NOTED AFTER THE TUG TEST. THE BALLOON WAS PLACED IN WATER AND AIR WAS INJECTED INTO THE INFLATION LUMEN AGAIN. NO LEAK WAS NOTED. THE RETURNED CATHETER COULD NOT BE ASPIRATED OR FLUSHED SUCCESSFULLY DUE TO THE CRACKED INJECTION LUMEN EXTENSION LINE LUER. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS. THE DEVICE PASSED ALL MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THE REPORTED COMPLAINT FOR "CRACK" IS CONFIRMED. DURING THE COMPLAINT INVESTIGATION, THE INJECTION LU-MEN EXTENSION LINE LUER WAS NOTED CRACKED, WHICH CAUSED THE REPORTED COMPLAINT. THE CRACKED LUER WOULD IMPEDE PROPER ASPIRATION AND FLUSHING OF THE INJECTION LUMEN. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD (DHR), THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE CRACKED INJECTION LUMEN EXTENSION LINE LUER. THE PROBABLE ROOT CAUSE OF THE COMPLAINT IS UNDETERMINED. A NON-CONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THE ISSUE.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720, 3010532612-2025-00735.

    Description of Event or Problem · 0

    IT WAS REPORTED "WE USED 3 EACH ARROW 5F BWP CATHETERS ON A PATIENT TODAY BECAUSE TWO OFTHEM DREW BACK AIR WHEN THE DR TRIED TO PULL BACK BLOOD; ONE APPEARS TO HAVE A HOLE IN IT AND THE OTHER A CRACK---ON THE HUBS? THERE WAS NO DIFFICULTY CONNECTING IT TO THE CATHETER NOR DISCONNECTING IT FROM THE CATHETER". NO PATIENT INJURY OR CONSEQUENCE REPORTED. THE PATIENT'S CURRENT CONDITION IS "UNKNOWN". PLEASE SEE ASSOCIATED MDR #: 3010532612-2025-00720 ,3010532612-2025-00736, 3010532612-2025-00735.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193246 ARROW CATH PKGD: WEDGE 5 FR 110CM CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC 16F25E0084 00801902002853

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.| N/A.