BEUDAMED
    FDA Adverse Event Death Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 11812979 · Received May 12, 2021

    Report

    Report Number
    2029214-2021-00564
    Event Type
    Death
    Date Received
    May 12, 2021
    Date of Event
    April 9, 2021
    Report Date
    August 30, 2021
    Manufacturer
    FUJI SYSTEMS CORPORATION
    Product Code
    DQY
    PMA / PMN Number
    K120781
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    H3. PRODUCT ANALYSIS: THE CELLO BALLOON GUIDE CATHETER (MODEL: 1610590, LOT: 5000139) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN A RESEALABLE BIOHAZARD BAG. THE CELLO BALLOON GUIDE CATHETER OUTER CARTON AND INNER POUCH WERE NOT RETURNED FOR ANALYSIS. IN ADDITION, IMAGES OF THE CELLO BALLOON GUIDE CATHETER OUTER CARTON AND INNER POUCH WERE NOT PROVIDED FOR ANALYSIS. THE 5F DILATOR WAS NOT RETURNED. THE CELLO BALLOON GUIDE CATHETER TOTAL LENGTH WAS MEASURED TO BE ~100.5CM. THE CELLO BALLOON GUIDE CATHETER USEABLE LENGTH WAS MEASURED TO BE ~92.1CM. NO ISSUES WERE FOUND WITH THE MAIN LUMEN OR BALLOON LUMEN HUB. A LUER WAS FOUND ATTACHED TO THE BALLOON LUMEN HUB. THE LUER WAS THEN REMOVED. THE BALLOON INFLATION PORT WAS FOUND TO BE INTACT. NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE DISTAL TIP. THE CATHETER BODY WAS FOUND TO BE KINKED AND CRACKED AT ~82.4CM, KINKED AT ~60.0CM, AT ~37.1CM AND FLATTENED AT ~3.2CM FOR ~2.5CM FROM DISTAL TIP. UPON VISUAL INSPECTION, NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE DISTAL TIP OR BALLOON. NO OTHER ANOMALIES WERE OBSERVED. THE CELLO BALLOON GUIDE CATHETER WILL BE SENT TO FUJI CORP. FOR FURTHER INVESTIGATION PER FUJI INVESTIGATION REPORT, "WE DID NOT USE ANY TOOL SPECIFICATIONS OR PROCESSES TO DAMAGE THE RELATED PARTS OF THE RETURNED PRODUCT, AND ALL PRODUCTS WERE INSPECTED THERE WAS NOT ANY RESISTANCE IN THE INNER TUBE CAUSED BY KINK AT THE MANUFACTURING PROCESS. THEREFORE, IF THERE IS A KINK ON A SHAFT, IT IS DETECTED AN NEVER BE SHIPPED TO A MARKET. BASED ON THE ABOVE RESULTS, WE CONSIDER THAT THE KINKS, CRUSHES AND THE LEAKAGE WERE CAUSED BY SOME REASON AFTER THE SHIPMENT." MEDICAL SAFETY REVIEW DETERMINED: "THE REPORTED EVENT IN THIS CASE DESCRIBES A PATIENT WHO WAS UNDERGOING MECHANICAL THROMBECTOMY FOR A LARGE BASILAR STROKE IN WHICH A CELLO BALLOON CATHETER WAS USED. IT WAS REPORTED THE DEVICE BECAME CRUSHED IN THE DISTAL SECTION AFTER IT WAS PLACED IN A STENOTIC PORTION OF THE VESSEL. THE DEVICE WAS REPLACED AND NO PATIENT SYMPTOMS WERE ASSOCIATED WITH THIS EVENT. THE MECHANICAL THROMBECTOMY PROCEDURE WAS SUCCESSFUL IN RETRIEVING THE CLOT AND THERE WERE NO OTHER DEVICE OR PROCEDURAL COMPLICATIONS. HOWEVER, THE PATIENT NEVER RECOVERED AND DID NOT WAKE FROM SURGERY. PATIENT MEDICAL HISTORY INCLUDES BASILAR STROKE AFTER NECK SURGERY. THE DEATH IN THIS CASE AND ITS REPORTED SEVERITY IS ASSESSED AS NOT RELATED TO THE DEVICE OR PROCEDURE BUT RATHER TO THE PATIENT'S PRESENTING BASELINE MEDICAL CONDITION. NO FURTHER ACTION IS RECOMMENDED." H6. CODING UPDATED BASED ON ANALYSIS AND MEDICAL SAFETY REVIEW. MEDTRONIC IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    MEDTRONIC RECEIVED A REPORT THAT THE DISTAL PART OF THE CELLO BALLOON CATHETER BECAME CRUSHED. THE CATHETER WAS PLACED IN STENOTIC PORTION OF VESSEL. THE CELLO WAS REPLACED, AND THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS ASSOCIATED WITH THIS EVENT. THE DEVICES WERE PREPARED AND FLUSHED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU). THE PATIENT WAS UNDERGOING TREATMENT FOR A STROKE. THE PATIENT'S VESSEL TORTUOSITY WAS MINIMAL. THE ACCESS VESSEL WAS THE RIGHT VERTEBRAL, WHICH WAS 4MM IN DIAMETER. IT WAS REPORTED THAT THE PATIENT NEVER AWOKE FROM SURGERY. IMAGING SHOWED A LARGE BASILAR STROKE. THE CLOT WAS REMOVED, BUT THE PATIENT NEVER RECOVERED.¿ ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT DIED THE DAY AFTER THE PROCEDURE ON (B)(6) 2021. THE CAUSE OF DEATH WAS DETERMINED TO BE "STROKE RELATED." THERE WERE NO DEVICE OR PROCEDURE ISSUE RELATED TO PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708947 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS DQY FUJI SYSTEMS CORPORATION 1610590 5000139

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Death