BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE 18 LP LOW PROFILE BALLOON CATHETER

    MDR report key: 7446630 · Received April 20, 2018

    Report

    Report Number
    1820334-2018-00981
    Event Type
    Injury
    Date Received
    April 20, 2018
    Date of Event
    March 21, 2018
    Report Date
    June 29, 2018
    Manufacturer
    COOK INC
    Product Code
    LIT
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER REGARDING THE REPORTED INCIDENT. THE CUSTOMER CONFIRMED THAT THE DEVICE PART REMAINED IN THE PATIENT'S BODY NO ATTEMPT AT REMOVAL WAS MADE. THE PATIENT'S OUTCOME WAS CHARACTERIZED OVERALL AS "OK." THE CUSTOMER ALSO CONFIRMED THAT THE RUBICON DEVICE WHICH WAS USED IN CONJUNCTION WITH THE COMPLAINT DEVICE WAS ONLY USED TO PUSH THE COMPLAINT DEVICE FOLLOWING THE RUPTURE OF THE PRODUCT. IT WAS UNKNOWN IF THE BALLOON AND SHEATH WERE REMOVED AS A UNIT. THE OPERATOR OF THE DEVICE REPORTEDLY DID NOT LIKELY REMOVE THE CATHETER IN A GENTLE CLOCKWISE MOTION, AS THIS WAS NOT THE OPERATOR'S NORMAL METHOD OF REMOVAL WHEN USING THE PRODUCT. LASTLY, THE CUSTOMER CONFIRMED THAT, WHEN RESISTANCE WAS FIRST FELT DURING THE USAGE OF THE DEVICE, NEGATIVE PRESSURE WAS NOT APPLIED WITH A LARGER SYRINGE PRIOR TO PROCEEDING BECAUSE, BY THAT TIME, THE BALLOON HAD REPORTEDLY RUPTURED; THEREFORE, NO FURTHER PRESSURE COULD BE APPLIED. INVESTIGATION EVALUATION: A REVIEW OF THE COMPLAINT HISTORY, DOCUMENTATION, INSTRUCTIONS FOR USE (IFU), QUALITY CONTROL, AND SPECIFICATIONS WAS CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED; HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE WAS DETERMINED TO BE RELATED TO THE PATIENT¿S CONDITION AND THE NATURE OF THE PROCEDURE. MEASURES ARE BEING CONDUCTED TO ADDRESS THIS FAILURE MODE. WE WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT. REFER TO FOR INVESTIGATIONAL FINDINGS.

    Additional Manufacturer Narrative · 1

    PER THE INITIAL REPORTER, THE DEVICE WILL NOT BE RETURNED. (B)(4). PMA/510(K) NUMBER = K130293. 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 THAT DURING A BALLOON ANGIOPLASTY OF THE VERY HIGHLY CALCIFIED ANTERIOR TIBIAL ARTERY, THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER BURST LEAVING A PIECE OF THE DEVICE IN THE PATIENTS VESSEL. THE PATIENT REPORTEDLY HAD A FOOT WOUND AND WAS UNDERGOING AN ANGIOPLASTY AS THE LAST ATTEMPT TO IMPROVE BLOOD FLOW. THERE WERE SEVERAL UNSPECIFIED PROBLEMS REGARDING THE ARTERIES OF THIS LIMB. AS THE BALLOON WAS DILATED TO 6 "BARS" IT BURST AS CONTACTED THE SHARP CALCIFICATIONS OF THE ARTERIA TIBIALIS ANTERIOR (ATA). THE TIP OF THE BALLOON GOT STUCK, AND AS THE BALLOON CATHETER WAS BEING REMOVED, IT BROKE AND THE TIP WAS LEFT IN THE DISTAL END OF THE ATA. THE PHYSICIAN TRIED TO PUSH THE BROKEN PART OF THE ADVANCE 18 LP LOW PROFILE BALLOON CATHETER TO A LARGER PART OF THE VESSEL WITH ANOTHER MANUFACTURER'S SUPPORT CATHETER WITHOUT SUCCESS. THIS SECOND SUPPORT CATHETER REPORTEDLY ALSO BROKE AND A PIECE WAS LEFT IN THE PATIENT'S VESSEL. ADDITIONAL INFORMATION REGARDING EVENT DETAILS, PATIENT ANATOMY AND OUTCOME HAS BEEN REQUESTED, BUT IS NOT AVAILABLE AT THIS TIME

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289368 ADVANCE 18 LP LOW PROFILE BALLOON CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL LIT COOK INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention