BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 10344556 · Received July 30, 2020

    Report

    Report Number
    2029214-2020-00749
    Event Type
    Malfunction
    Date Received
    July 30, 2020
    Date of Event
    July 13, 2020
    Report Date
    December 14, 2020
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS #(B)(4): EQUIPMENT USED: VIS (B)(6), 203CM RULER (B)(6) THE CELLO BALLOON GUIDE CATHETER (MODEL: 1610090, LOT: 1610090) WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX AND WITHIN AN OPENED CELLO OUTER CARTON. THE CELLO BALLOON GUIDE CATHETER WAS DECONTAMINATED AS PER MANUFACTURER PROTOCOLS. THE CELLO TOTAL LENGTH WAS MEASURED TO BE ~100.2CM. THE CELLO USABLE LENGTH WAS MEASURED TO BE ~91.5CM. THE BALLOON INFLATION PORT WAS FOUND TO BE DETACHED AND NOT RETURNED. THE REASON FOR THE BALLOON INFLATION PORT NOT RETURNING WAS NOT PROVIDED. NO DAMAGES WERE FOUND WITH EITHER THE MAIN LUMEN OR BALLOON LUMEN HUBS. THE CELLO BALLOON GUIDE CATHETER BODY WAS FOUND KINKED ~34.3CM, ~43.4CM, ~57.5CM AND ~90.0CM FROM THE PROXIMAL END OF THE MAIN HUB. UPON VISUAL INSPECTION, NO ISSUES OR IRREGULARITIES WERE FOUND WITH THE BALLOON. NO OTHER ANOMALIES WERE OBSERVED. THE CELLO BALLOON GUIDE CATHETERS WAS SENT TO FUJI CORP. FOR FURTHER INVESTIGATION. PER THE FUJI INVESTIGATION REPORT, ¿WE OBSERVED THE RETURNED DEVICE AND FOUND THE CRACK IN THE HUB CONNECTING TO THE BALLOON PATH, ALSO FOUND THE LEAK FROM THE DAMAGED PART AS WE INJECTED WATER. THE BALLOON INJECTION PORT THAT WERE CONNECTED AT SHIPMENT HAD BEEN MISSED AND NOT RETURNED TO US. FOUR POINTS 115MM, 430MM, 570MM, 660MM FROM THE TIP OF CATHETER WERE COMPLETED KINKED. WE CONFIRMED THAT THERE WAS NOT ANY PROBLEM FOR PRODUCT RECORD AND INSPECTION RECORD. WE DON¿T USE ANY METHODS WHICH MAY DAMAGE THE RELEVANT PLACE DURING MANUFACTURING OPERATION. FURTHERMORE, WE INSPECT ALL PRODUCT BY INJECTING AIR TO BALLOON AFTER PROCESS. THEREFORE, SUCH COMPLAINED PRODUCT MUST HAVE BEEN FOUND BEFORE SHIPPING IF THE HUB WAS BROKEN. BASED ON THE INVESTIGATION, IT IS PRESUMED THAT SYRINGE OR SOMETHING ALIKE WAS CONNECTED TO THE HUBS DIRECTLY OR SIMILAR THINGS HAPPENED." 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS ORIGINALLY CODED AND REPORTED FOR BALLOON RUPTURE. NEITHER INITIAL REPORT NOR ANALYSIS PREVIOUS REPORTED NOTED THAT THE BALLOON RUPTURED BUT ONLY THAT THERE WAS A CRACK/LEAK AT THE HUB AND THE BALLOON FAILED TO INFLATE. 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. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MDR DECISION CORRECTED TO NOT REPORTABLE. NO ADDITIONAL SUPPLEMENT REPORTS ARE REQUIRED UNLESS ADDITIONAL INFORMATION RECEIVED INDICATES REPORTABLE EVENT.

    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 WHEN MANIPULATING THE CELLO BALLOON CATHETER ON THE OPERATING TABLE, THERE WAS A LEAK AT THE HUB OF THE CATHETER WHERE THE BALLOON IS INFLATED, AND THE BALLOON WOULD NOT INFLATE. THE LEAK WAS OBERSEVED DURING PREPARATION, AND ALL DEVICES WERE PREPARED AS PER THE INSTRUCTIONS FOR USE (IFU). THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS WITH THE EVENT. ADDITIONAL INFORMATION RECEIVED ON 24-JUL-2020 REPORTED THAT WHEN REMOVING THE AIR FROM THE BALLOON DURING PREPARATION IT WAS NOTICED THAT THE BALLOON'S INFLATION HUB WAS CRACKED AND LEAKING LIQUID, CAUSING THE BALLOON TO NOT INFLATE. NO EXCESSIVE FORCE WAS APPLIED WHEN CONNECTING THE Y CONNECTOR OR SYRINGE TO THE CATHETER HUB. THE GUIDEWIRE USED WAS HYDROPHILIC STIFF .035, AND THERE WAS NO EXTENSIVE GUIDEWIRE MANIPULATION. THE GUIDEWIRE TIP WAS NOT SHAPED, AND THE CONTRAST RATIO WAS .5 ML OF CONTRAST AND .5 ML OF SERUM. THE INJECTION RATE WAS SLOW. THE DEVICES WERE FLUSHED AND HYDRATED ACCORDING TO THE INSTRUCTIONS FOR USE (IFU).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    812078 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MICRO THERAPEUTICS, INC. DBA EV3 1610090 1610090

    Patients

    Seq Age Sex Outcome Treatment
    1