BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6816706 · Received August 24, 2017

    Report

    Report Number
    1820334-2017-02703
    Event Type
    Malfunction
    Date Received
    August 24, 2017
    Date of Event
    August 18, 2017
    Report Date
    November 22, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    UDI-DI
    10827002343372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: ATTEMPTS FOR THE RETURN OF THE PRODUCT AS WELL AS PATIENT AND PROCEDURAL INFORMATION WERE MADE; HOWEVER, NO INFORMATION WAS PROVIDED. PMA/510(K) # :K130293. INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DEVICE HISTORY RECORD, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, SPECIFICATIONS, AND QUALITY CONTROL, WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATION COULD BE PERFORMED. HOWEVER, A DOCUMENT-BASED INVESTIGATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE FINISHED PRODUCT WAS NOT MADE TO SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORD OF THE FINISHED PRODUCT SHOWS TWO NONCONFORMING EVENTS; HOWEVER, ALL PRODUCT WAS SCRAPPED BEFORE THE LOT WAS PROCESSED AS NORMAL. THERE WERE NO OTHER REPORTED COMPLAINTS FOR THIS LOT NUMBER. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED, AND THE RESULTS OF OUR INVESTIGATION; A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE QUALITY ENGINEERING RISK ASSESSMENT, NO FURTHER ACTION IS REQUIRED. APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED AND MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) #: K130293. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A SUPPLEMENTAL REPORT WILL BE PROVIDED UPON CONCLUSION.

    Description of Event or Problem · 1

    AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVICE WAS USED IN A LEG PROCEDURE VIA RETROGRADE AT ACCESS. IT WAS REPORTED THAT THE BALLOON BURST AT LOW INFLATION IN THE SFA LESION. DURING THE SAME PROCEDURE, IT WAS REPORTED THAT ANOTHER SIMILAR ADVANCE 18 LP LOW PROFILE BALLOON CATHETER DEVICE WAS ALSO USED AND THE BALLOON ALLEGEDLY BURST AT LOW INFLATION IN THE SFA LESION AS WELL. BECAUSE OF THE DIFFERING LOT NUMBERS, THIS DEVICE HAS BEEN REPORTED UNDER (B)(4) AND MANUFACTURER REPORT NUMBER 1820334-2017-02704. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    597506 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A 10827002343372

    Patients

    Seq Age Sex Outcome Treatment
    1