BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 5 FR 80CM

    MDR report key: 17148514 · Received June 16, 2023

    Report

    Report Number
    3010532612-2023-00326
    Event Type
    Malfunction
    Date Received
    June 16, 2023
    Date of Event
    May 25, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DYG
    UDI-DI
    00801902002273
    PMA / PMN Number
    K892530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE REPORTED COMPLAINT THAT THE "CATHETER GOT TORN DURING THE PROCEDURE" WAS CONFIRMED. THE CUSTOMER RETURNED A 5FR. 80CM BERMAN CATHETER WITH THE ORIGINAL PACKAGING POUCH (INP-3, INP-7) FOR INVESTIGATION. THE SAMPLE WAS RETURNED IN THE UPS SHIPPING BOX AND WAS IN A SEALED ZIPLOC BAG (INP-1, INP-2). THE SAMPLE WAS LOOSELY PACKED WITHIN THE ORIGINAL PACKAGING POUCH (INP-5). UPON RETURN, THE CATHETER BODY WAS IMMEDIATELY NOTED RUPTURED NEAR THE JUNCTION HUB; THE BODY WAS NOTED RUPTURED FROM APPROXIMATELY 88.7CM TO 89.2CM FROM THE DISTAL TIP OF THE CATHETER (INP-11, INP-12). THE SUPPLIED CONTROL STROKE SYRINGE WAS NOTED CONNECTED TO THE INFLATION LUMEN STOPCOCK; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE RETURNED SYRINGE (INP-8). THE INFLATION LUMEN STOPCOCK WAS IN THE OPEN POSITION (INP-8). THE RECOMMENDED VOLUME CAPACITY OF THE BALLOON IS 0.75CC (INP-9). UPON MICROSCOPIC INSPECTION, THE BALLOON APPEARED TYPICAL; NO DAMAGE OR ABNORMALITIES WERE NOTED TO THE BALLOON (INP-10). DRIED BLOOD WAS NOTED WITHIN THE BERMAN HOLES (INP-13, INP-14). NO CONDENSATION WAS NOTED WITHIN THE INFLATION LUMEN EXTENSION LINE. SOME DRIED BLOOD/CONTRAST MEDIA WAS NOTED WITHIN THE INJECTION LU MEN EXTENSION LINE (INP-15). SPOTS OF DRIED BLOOD/CONTRAST MEDIA WAS NOTED ON THE EXTERIOR SURFACES OF THE RETURNED SAMPLE. NO OTHER DAMAGE OR ABNORMALITIES WERE NOTED. THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. THE BALLOON INFLATED SYMMETRICALLY (ANP-1, ANP-2). BOTH THE SIDES OF THE BALLOON MEASURED APPROXIMATELY 4MM EACH. THE BALLOON DID MEET SPECIFICATIONS PER GRAPHIC OF RADIUS RATIO LESS THAN OR EQUAL TO 2.0. UPON FUNCTIONAL INSPECTION, THE BALLOON INFLATED SYMMETRICALLY (ANP-1, ANP-2), WHEN THE INFLATION LUMEN WAS INJECTED WITH 0.75CC OF AIR USING THE RETURNED CONTROL STROKE SYRINGE. 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 RUPTURED CATHETER BODY DID NOT RESULT IN DAMAGE TO THE INFLATION LUMEN. THE CATHETER'S INJECTION LUMEN WAS ASPIRATED/FLUSHED, AND AIR WAS NOTED LEAKING FROM THE RUPTURED CATHETER BODY (ANP-3). A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR THE LOT NUMBER WITH NO RELEVANT FINDINGS AND THE PRODUCT MET SPECIFICATION UPON RELEASE; HOWEVER, THE SPECIFICATIONS WERE NOT MET DURING THE COMPLAINT INVESTIGATION DUE TO THE RUPTURED CATHETER BODY. THE PROBABLE ROOT CAUSE OF THE COMPLAINT IS MANUFACTURING RELATED. CAPA HAS BEEN INITIATED UNDER TELEFLEX'S QUALITY SYSTEM BY THE MANUFACTURING SITE TO ADDRESS THIS COMPLAINT ISSUE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." ASSOCIATED MDR 3010532612-2023-00327. ADDITIONAL INFORMATION RECEIVED STATED "BOTH CATHETERS GOT TORN AT THE BASE, WHERE THE BALLOON LUMEN AND THE INJECTION LUMEN MEET, AND THE CONTRAST MEDIA LEAKED. THE CONTRAST MEDIA USED: OMNIPAQUE 350. INJECTION RATE: 1. 8CC/SEC, 12CC MEASURED MAXIMUM INJECTION PRESSURE: 496PSI. 2. 6CC/SEC 12CC MEASURED MAXIMUM INJECTION PRESSURE: 538PSI.".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE CATHETER GOT TORN DURING THE PROCEDURE. THE CATHETER WAS REPLACED WITH A NEW ONE, INSERTED AT THE SAME INSERTION SITE, BUT THE SAME ISSUE OCCURRED. THEREFORE, THE THIRD CATHETER WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT WAS REPORTED." ASSOCIATED MDR 3010532612-2023-00327. ADDITIONAL INFORMATION RECEIVED STATED "BOTH CATHETERS GOT TORN AT THE BASE, WHERE THE BALLOON LUMEN AND THE INJECTION LUMEN MEET, AND THE CONTRAST MEDIA LEAKED. THE CONTRAST MEDIA USED: OMNIPAQUE 350. INJECTION RATE: 1. 8CC/SEC, 12CC MEASURED MAXIMUM INJECTION PRESSURE: 496PSI. 2. 6CC/SEC 12CC MEASURED MAXIMUM INJECTION PRESSURE: 538PSI."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709435 CATH PKGD: BERMAN 5 FR 80CM CATHETER, FLOW DIRECTED DYG ARROW INTERNATIONAL LLC IPN000083 16F22L0062 00801902002273

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NONE REPORTED| NONE REPORTED