BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATH PKGD: BERMAN 4 FR 5 0CM

    MDR report key: 2080066 · Received April 7, 2011

    Report

    Report Number
    2242445-2011-00038
    Event Type
    Malfunction
    Date Received
    April 7, 2011
    Date of Event
    January 19, 2011
    Report Date
    April 5, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQO
    PMA / PMN Number
    PREAMENDMENT
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT WAS INITIALLY EVALUATED AND DETERMINED TO BE NON-REPORTABLE. THE RETURNED DEVICE WAS EVALUATED AND THE EVENT WAS DETERMINED TO BE A RESULT OF A PRODUCT MALFUNCTION, THEREFORE IT IS REPORTABLE. DEVICE EVAL: ONE BERMAN CATHETER WAS RETURNED FOR EVALUATION. THE CATHETER WAS VISUALLY EXAMINED, FUNCTIONALLY TESTED AND IDENTIFIED ON THE JUNCTURE HUB AS A "4 FR BERMAN ARROW." THE CATHETER AND DISTAL EXTENSION LINE APPEARED TYPICAL. THE STOPCOCK EXHIBITED A YELLOW FOREIGN MATERIAL IN THE LUER HUB, BUT PASSAGE THROUGH THE STOPCOCK APPEARED CLEAR. MICROSCOPIC EXAMINATION OF THE CATHETER AND THE BALLOON REVEALED THE BERMAN HOLES WERE CLEAR, THE CATHETER APPEARED TYPICAL AND STRIATIONS WERE OBSERVED ON THE BALLOON AT BOTH THE PROXIMAL AND DISTAL GLUE LINES. NO OTHER DEFECTS OR ANOMALIES WERE OBSERVED. THE FOREIGN MATERIAL WAS REMOVED FROM THE STOPCOCK AND A 1.10 CC LAB INVENTORY SYRINGE WAS ATTACHED TO THE INFLATION LUMEN, 0.60 CC OF AIR WAS INJECTED INTO THE INFLATION LUMEN PER INFLATION LUMEN LUER; THE BALLOON DID NOT INFLATE. THE CATHETER WAS SUBMERGED IN WATER AND 0.60 CC OF AIR WAS INJECTED INTO THE INFLATION LUMEN. AGAIN THE BALLOON DID NOT INFLATE, BUT BUBBLES EXITED THE DISTAL EXTENSION LINE HUB INDICATING A POSSIBLE CROSSOVER. WHILE THE CATHETER WAS SUBMERGED, 1.10 CC OF AIR WAS INJECTED INTO THE DISTAL LUMEN; BUBBLES EXITED THE BERMAN HOLES (AS EXPECTED) AND INFLATION LUMEN INDICATING A CROSSOVER. TO CONFIRM THE LOCATION OF THE INTERLUMEN CROSSOVER, THE CATHETER WAS CLAMPED JUST BELOW THE JUNCTURE HUB AND 1.10 CC OF AIR WAS AGAIN INJECTED INTO THE DISTAL LUMEN WHILE THE CATHETER WAS STILL SUBMERGED IN WATER; BUBBLES WERE OBSERVED EXITING THE INFLATION LUMEN. THEN, 0.60 CC OF AIR WAS INJECTED INTO THE INFLATION LUMEN AND AGAIN BUBBLES EXITED THE DISTAL HUB CONFIRMING A CROSSOVER IN THE JUNCTURE HUB. THE JUNCTURE HUB WAS CROSS-SECTIONED AND MICROSCOPICALLY EXAMINED. A LARGE VOID WAS OBSERVED WITHIN THE JUNCTURE HUB CONFIRMING THE COMMUNICATION BETWEEN THE TWO LUMENS. AN ATTEMPT WAS MADE TO INFLATE THE BALLOON BY ATTACHING A DISPENSING TIP AND 1.10 CC LAB INVENTORY SYRINGE TO THE INFLATION LUMEN OF THE CUT CATHETER BODY AND INJECTING 0.60 CC OF AIR INTO THE INFLATION LUMEN; THE BALLOON DID NOT INFLATE. A 0.009 "LAB INVENTORY SPRING WIRE GUIDE (SWG) WAS INSERTED INTO THE INFLATION LUMEN, BUT HIT A BLOCKAGE AND COULD NOT PASS THROUGH. THE CATHETER BODY WAS CROSS-SECTIONED AND MICROSCOPICALLY EXAMINED TO CONFIRM THE BLOCKAGE. THE INFLATION LUMEN WAS BLOCKED LIKELY WITH CONTRAST AS A RESULT OF THE INTERLUMEN CROSSOVER. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE REPORTED COMPLAINT OF BALLOON LEAKED WHEN INJECTED WITH CONTRAST WAS CONFIRMED THROUGH FUNCTIONAL TESTING OF THE RETURNED CATHETER. MICROSCOPIC EXAMINATION REVEALED A VOID IN THE JUNCTURE HUB ALLOWING COMMUNICATION BETWEEN THE DISTAL LUMEN AND THE INFLATION LUMEN. AS A RESULT, THE POTENTIAL CAUSE OF THIS COMPLAINT IS MANUFACTURING RELATED. A NONCONFORMANCE HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS ISSUE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SETUP, THE BALLOON WAS FOUND LEAKING WHEN INJECTING THE CONTRAST. THE BALLOON PRESSURE WAS 500 PSI. AS A RESULT, THE AI-07134 WAS NOT USED. THERE WAS NO REPORTED PATIENT DEATH OR INJURY. MEDICAL/SURGICAL INTERVENTION WAS NOT REQUIRED. THERE WAS NO REPORTED DELAY IN THERAPY. ANOTHER KIT WAS OPENED, PREPPED AND USED WITHOUT DIFFICULTY. NO PATIENT COMPLICATIONS REPORTED. THE PATIENT OUTCOME IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATH PKGD: BERMAN 4 FR 5 0CM BERMAN ANGIOGRAPHIC CATHETER PRODUCTS DQO ARROW INTL., INC. MF9110217

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR