BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER

    MDR report key: 6978188 · Received October 25, 2017

    Report

    Report Number
    1820334-2017-03639
    Event Type
    Injury
    Date Received
    October 25, 2017
    Date of Event
    October 17, 2017
    Report Date
    February 15, 2018
    Manufacturer
    COOK INC
    Product Code
    LIT
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION - EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DIMENSIONAL VERIFICATION, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, TRENDS, QUALITY CONTROL, AND VISUAL INSPECTION OF THE RETURNED DEVICE WAS CONDUCTED DURING THE INVESTIGATION. ONE USED ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER WAS RETURNED FOR INVESTIGATION. THE BALLOON IS SEPARATED AT THE PROXIMAL BOND SITE. BOTH MARKER BANDS ARE PRESENT. THE DISTAL SEPARATED PORTION OF THE BALLOON IS SNARED WITH A RETURNED UNKNOWN 4 FRENCH SNARE DEVICE. AN UNKNOWN WIRE GUIDE IS A ALSO PRESENT. THE TOTAL LENGTH AND THE BALLOON LENGTH ARE WITHIN SPECIFICATION. THE COMPLAINANT DEVICE LOT NUMBER IS UNKNOWN. THUS, A REVIEW OF THE DEVICE HISTORY RECORD, NONCONFORMANCE HISTORY, AND RELATED PRODUCT COMPLAINTS QUERY COULD NOT BE CONDUCTED. PER THE CUSTOMER, THE VASCULAR WAS TORTUOUS, AND ¿A COUNTER CLOCKWISE ROTATION WAS NOT KNOWN TO BE USED DURING WITHDRAWAL.¿ THE IFU STATES, ¿CHOOSE A BALLOON APPROPRIATE TO LESION LENGTH AND VESSEL DIAMETER.¿ AND, "UPON CATHETER WITHDRAWAL, A GENTLE COUNTERCLOCKWISE ROTATION OF THE CATHETER WILL ASSIST BALLOON REWRAP, MINIMIZING TRAUMA TO THE PERCUTANEOUS ENTRY SITE.¿ BASED ON THE INFORMATION PROVIDED, EXAMINATION OF THE RETURNED PRODUCT, 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

    ADDITIONAL INFORMATION: PMA/510(K) #K130293. (B)(4). 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 PTA BALLOON DILATATION CATHETER WAS USED IN A PERCUTANEOUS TRANSLUMINAL ANGIO PROCEDURE. IT WAS REPORTED THAT, THE TARGET SITE WAS ACCESSED VIA THE ARM, AS THE GROIN COULD NOT BE ACCESSED. IT WAS REPORTED THERE WAS TORTUOSITY OF THE ARTIRICAL SYSTEM AND CALCIFICATION OF TB TRUNK. UPON PULLING THE BALLOON BACK AFTER THE PROCEDURE WAS COMPLETE, THE WIRE WAS LOOPED (THIS WAS NOT NOTICED AS A RUN WAS NOT PERFORMED) AND THE BALLOON SHEERED OFF AND HAD TO BE RETRIEVED WITH A SNARE. 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
    756022 ADVANCE 18 LP LOW PROFILE PTA BALLOON DILATATION CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention