BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 6785495 · Received August 10, 2017

    Report

    Report Number
    1820334-2017-02488
    Event Type
    Injury
    Date Received
    August 10, 2017
    Date of Event
    August 4, 2017
    Report Date
    October 25, 2017
    Manufacturer
    COOK INC
    Product Code
    LIT
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PMA/510(K) # : K130293. THE REPORTED DEVICE IS NOT AVAILABLE FOR EVALUATION. THE EVENT IS CURRENTLY UNDER INVESTIGATION.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: EVENT DESCRIPTION: THE BALLOON WAS INFLATED TO ABOVE NOMINAL BUT BELOW BURST PRESSURE ON A HEAVILY CALCIFIED VESSEL. A REVIEW OF DOCUMENTATION, SPECIFICATIONS, DRAWINGS, INSTRUCTIONS FOR USE (IFU), AND QUALITY CONTROL DATA WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE NO PHYSICAL EXAMINATION COULD BE PERFORMED. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY A REVIEW OF THE DEVICE HISTORY RECORD AND COMPLAINT HISTORY OF THE LOT COULD NOT BE CONDUCTED. THERE IS NO INFORMATION REGARDING THE REMOVAL OF THE DEVICE FOLLOWING THE RUPTURE. PER THE IFU, "UPON CATHETER WITHDRAWAL, A GENTLE COUNTERCLOCKWISE ROTATION OF THE CATHETER WILL ASSIST BALLOON REWRAP, MINIMIZING TRAUMA TO THE PERCUTANEOUS ENTRY SITE. IF RESISTANCE IS MET DURING WITHDRAWAL, APPLY NEGATIVE PRESSURE WITH A LARGER SYRINGE BEFORE PROCEEDING. IF RESISTANCE CONTINUES, REMOVE BALLOON AND SHEATH AS UNIT." THERE IS NO INFORMATION REGARDING THE CONTRAST TO SALINE MIXTURE. PER THE IFU, "PREPARE BALLOON LUMEN WITH STANDARD CONTRAST-SALINE MIXTURE AS FOLLOWS: FILL A SYRINGE OF APPROPRIATE SIZE WITH 11 MIXTURE OF CONTRAST MEDIUM AND NORMAL SALINE." PER THE CUSTOMER, THERE WAS CALCIFICATION. PER THE IFU, "THE BALLOON IS MANUFACTURED FROM AN EXTRA-THINWALL, HIGH-STRENGTH, MINIMALLY-COMPLIANT MATERIAL. PARTICULAR CARE SHOULD BE TAKEN IN HANDLING THE BALLOON TO PREVENT DAMAGE." BASED UPON THE INFORMATION PROVIDED AND THE CHARACTERISTICS DISPLAYED, IT IS FEASIBLE TO SUGGEST THAT THIS INCIDENT WAS TECHNIQUE RELATED OR HUMAN ANATOMY RELATED. 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 WARRANTED. MONITORING WILL CONTINUE TO BE PERFORMED FOR SIMILAR COMPLAINTS.

    Description of Event or Problem · 1

    AN ADVANCE 18 LP LOW PROFILE BALLOON CATHETER WAS USED DURING A SUPERFICIAL FEMORAL ARTERY (SFA ) BALLOONING AND STENTING PROCEDURE. IT WAS REPORTED THAT THE PHYSICIAN WENT ANTIGRADE THROUGH ANOTHER MANUFACTURER'S 6FR SHEATH, AND THE BALLOON WAS USED TO PRE-DILATE. DURING DILATION THE BALLOON CIRCUMFERENTIALLY RUPTURED. WHEN TRYING TO REMOVE THE BALLOON, IT SEPARATED. A SNARE WAS USED TO REMOVE SEVERAL PIECES. DISTAL SFA ACCESS WAS NEEDED TO REMOVE THE REMAINING PIECES OF BALLOON. THE PHYSICIAN WAS THEN ABLE TO BALLOON AND STENT WITH ANOTHER DEVICE. NO HARM TO THE PATIENT AND, ACCORDING TO THE INITIAL REPORTER, NO ADDITIONAL PROCEDURES REQUIRED DUE TO THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    564693 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention