BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 14 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 8404449 · Received March 8, 2019

    Report

    Report Number
    1820334-2019-00560
    Event Type
    Malfunction
    Date Received
    March 8, 2019
    Date of Event
    November 5, 2018
    Report Date
    March 8, 2019
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002503264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PMA/510(K) NUMBER: K170193. CONCOMITANT MEDICAL PRODUCTS: WIRE: .014 WIRE, INFLATION DEVICE G25571. OCCUPATION: UNKNOWN. INVESTIGATION ¿ EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, DRAWING, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, QUALITY CONTROL, AND SPECIFICATIONS OF THE DEVICE, AS WELL AS A VISUAL INSPECTION AND FUNCTIONAL TEST, WERE CONDUCTED DURING THE INVESTIGATION. THE VISUAL INSPECTION OF THE COMPLAINT DEVICE REVEALED BIOMATTER WAS PRESENT ON THE BALLOON. NO SHAFT DAMAGE IS NOTED PROXIMAL TO THE BALLOON. SLIGHT TIP DAMAGE WAS ALSO NOTED AT THE DISTAL TIP OF THE DEVICE. THE BALLOON HAS A PINHOLE LEAK AT THE PROXIMAL END OF THE BALLOON. THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE WAS NOT MANUFACTURED TO SPECIFICATION. ADDITIONALLY, A DOCUMENT-BASED INVESTIGATION EVALUATION WAS PERFORMED FOR LOT 8903927 WAS REVIEWED AND NO NONCONFORMANCES WERE NOTED FOR ANY FAILURE. IT SHOULD BE NOTED THERE ARE NO OTHER COMPLAINTS FOR THE LOT 8903927. GIVEN THIS INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THERE IS ADDITIONAL NONCONFORMING PRODUCT IN HOUSE OR IN THE FIELD. BASED ON THE INFORMATION PROVIDED AND THE RESULTS OF THE INVESTIGATION, COOK HAS CONCLUDED THE CAUSE COULD NOT BE TRACED TO THE DEVICE. IT IS POSSIBLE THE PATIENT¿S ANATOMY CONTRIBUTED TO THIS EVENT. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED DURING ANGIOPLASTY OF AN UNSPECIFIED LEG, AN ADVANCE 14 LP LOW PROFILE BALLOON CATHETER WAS PLACED INSIDE THE ANTERIOR TIBIAL ARTERY AND INFLATED USING A COOK INFLATION DEVICE. INFLATION MEDIUM INFORMATION WAS NOT PROVIDED. ACCESS WAS GAINED FROM THE GROIN USING A COOK MICROPUNCTURE SET. NO INFORMATION WAS AVAILABLE REGARDING VESSEL SCARRING, TORTUOSITY, OR ANGULATION BUT IT WAS DESCRIBED AS "NOT OUT OF THE ORDINARY AND 50% STENOSED". THE GOAL WAS TO INFLATE THE DEVICE TO 8 ATMOSPHERES (ATM) BUT IT WOULD NOT INFLATE PAST 2 ATM. THE BALLOON WAS REMOVED FROM THE BODY AND INFLATED TO 8 ATM OUTSIDE OF THE STENT WITHOUT ISSUE. IT WAS REINSERTED ONCE AGAIN TO THE ANTERIOR TIBIAL ARTERY. AGAIN, AN ATTEMPT WAS MADE TO INFLATE THE BALLOON BUT IT NEVER INFLATED. THE PATIENT WAS NOT HARMED AND THEY COMPLETED THE PROCEDURE WITH NO ISSUES." THE PROCEDURE WAS COMPLETED USING ANOTHER COOK BALLOON AND NO ADVERSE EFFECTS WERE REPORTED. UPON RECEIPT OF THE COMPLAINT DEVICE, A PINHOLE WAS FOUND DURING PRELIMINARY INVESTIGATION ON 27-FEB-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197966 ADVANCE 14 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 8903927 10827002503264

    Patients

    Seq Age Sex Outcome Treatment
    1