BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CELLO BALLOON GUIDE CATHETER

    MDR report key: 17378308 · Received July 24, 2023

    Report

    Report Number
    3000308637-2023-00006
    Event Type
    Malfunction
    Date Received
    July 24, 2023
    Date of Event
    March 20, 2023
    Report Date
    July 24, 2023
    Manufacturer
    FUJI SYSTEMS CORPORATION
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PRODUCT ANALYSIS # (B)(4):, EQUIPMENT USED: VIS (M-85519), 203CM RULER (M-83361). DRAWING(S) REFERENCED: NONE, AS FOUND CONDITION: THE CELLO BALLOON GUIDE CATHETER WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN AN OPENED CELLO OUTER CARTON (5200217), AND WITHIN AN OPENED CELLO INNER POUCH (5200217). DAMAGE LOCATION DETAILS: NO DAMAGES WERE FOUND WITH THE CELLO MAIN LUMEN OR BALLOON LUMEN CATHETER HUBS. NO BENDS OR KINKS WERE FOUND WITH THE CELLO CATHETER BODY. THE CELLO BALLOON WAS FOUND TORN CIRCUMFERENTIALLY. PER THE FUJI INVESTIGATION REPORT, ¿THE ACTUAL SAMPLE RETURNED WAS WITHOUT THE BALLOON INJECTION PORT (EXTENSION CONNECTING TUBE) WHICH WAS A COMPONENT FOR THIS PRODUCT. ON THE VISUAL APPEARANCE OF THE SAMPLE, THE BALLOON WAS BEING FRACTURED GOING AROUND THE SHAFT, SEE PHOTO 2. THE CROSS SECTIONS OF THE BALLOON FRACTURED WERE MATCHED WHEN PUT THEM TOGETHER, SEE PHOTO 3. DUE TO THIS FACT, IT WAS DETERMINED THAT ANY MISSING PART OF THE BALLOON WAS NOT EXISTED. DETAILED INVESTIGATION ON THE PART OF BALLOON FRACTURED WAS CONDUCTED, AND ANY TRACE SUCH AS A DAMAGE TO IDENTIFY A CAUSE OF THE FRACTURE WAS NOT OBSERVED. AS FOR THE BALLOON ITSELF, A TEARING WAS NOT OCCURRED EVEN BEING PULLED AND ANY ABNORMALITY SUCH AS A DEGRADATION WAS NOT OBSERVED. FOR THE HUB, ANY ABNORMALITY SUCH AS A DAMAGE WHICH WOULD CAUSE A LEAKAGE WAS NOT OBSERVED, SEE PHOTO 4. FOR THE ENTIRE SAMPLE, ANY ABNORMALITY SUCH AS A DAMAGE WAS NOT OBSERVED EXCEPT THE BALLOON FRACTURED.¿ TESTING/ANALYSIS: PER THE FUJI INVESTIGATION REPORT, ¿WHEN TRYING TO INJECT WATER TO THE BALLOON LUMEN BY CONNECTING A SYRINGE TO THE BALLOON LUMEN CONNECTOR OF THE HUB TO CONFIRM THE SHAFT CONDITION, THE WATER WAS ABLE TO BE INJECTED WITHOUT ANY ANOMALOUS RESISTANCE, AND A LEAKAGE WAS OBSERVED WHERE THE BALLOON FRACTURED WAS. THEN, TRYING TO INJECT WATER TO THE BALLOON LUMEN CONNECTOR OF THE HUB BY THE SYRINGE AFTER THE SHAFT ON THE PROXIMAL SIDE OF THE BALLOON WAS CLAMPED, AS A RESULT, A STRONG RESISTANCE OCCURRED AND ANY LEAKAGE FROM THE BALLOON LUMEN OR THE HUB WAS NOT OBSERVED.¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S ¿CATHETER LEAK AT HUB/STRAIN RELIEF¿ COULD NOT BE CONFIRMED. NO LEAKS OR DAMAGES WERE FOUND WITH THE CATHETER HUBS. PER THE FUJI INVESTIGATION REPORT, ¿LOT NO. 5200217 WAS MANUFACTURED IN AUGUST, 2022 FOR (B)(4)UNITS. DUE TO THE BALLOON INJECTION PORT (EXTENSION CONNECTING TUBE) WAS NOT RETURNED, NO INVESTIGATION HAS BEEN HELD FOR THIS PART. WE REVIEWED OUR MANUFACTURING RECORDS AND IT WAS PROCESSED AS PER AS INSTRUCTIONS, AND ALSO ANY ABNORMALITY WAS NOT RECORDED ON THE INSPECTION RECORDS. FOR THE MANUFACTURING PROCESS OF THIS PRODUCT, TOOLS WHICH WOULD BE CAUSED A DAMAGE ON THE HUB AND/OR THE BALLOON ARE NOT USED, ALSO THERE ARE NO PROCESSES THAT WOULD BE CAUSED THE DAMAGE AS WELL. A 100% INSPECTION ON THE BALLOON FOR LEAKAGE BY INJECTING AIR IS CONDUCTED AFTER THE ASSEMBLY PROCESS FOR THIS PRODUCT. THEREFORE, ANY ABNORMALITY AGAINST A DAMAGE ON THE HUB OR THE BALLOON IS DETECTED DURING THE INSPECTION AND NOT ALLOWED TO BE SHIPPED OUT TO THE MARKET. BASED ON ABOVE INVESTIGATION FINDINGS, WE ASSUME THAT THE LEAKAGE WAS CAUSED BY THE BALLOON FRACTURED THAT OCCURRED FOR SOME REASON AT THE T IME OF USE, WHICH LED A MISPERCEPTION OF LEAKING FROM THE HUB.¿ (B)(6) (B)(6) 2023. 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

    MEDTRONIC RECEIVED INFORMATION THAT A CELLO 9F BALLOON GUIDE CATHETER WAS LEAKING AT THE HUB. OPERATOR HAS FLUSH ALL THE ACCESSORY DEVICES AS PER INSTRUCTIONS FOR UDE (IFU). HE HAS PLACED CELLO 9F AT THE LT COMMON CAROTID ARTERY (CCA) ITH THE HELP OF DILATOR 0.35 WIRE. BUT AFTER SOME TIME OPERATOR NOTICE THAT CONTRAST WAS LEAKING AT THE HUB OF CELLO. HENCE HE HAS DECIDED TO WITHDRAWN CELLO AND PUT 7F LONG SHEATH, THEN THROUGH LONG SHEATH HE HAD COMPLETED MECHANICAL THROMBECTOMY (MT) WITH ALL OTHER DEVICES. AND FINISH THE CASE. THERE WAS NO FORCE APPLIED WHILE CONNECTING THE Y CONNECTOR OR SYRINGE TO THE CATHETER HUB. THE CATHETER WAS INSPECTED PRIOR TO USE. THE LEAK WAS OBSERVED DURING USE. THE PATIENT WAS BEING TREATED FOR AN ACUTE ISCHEMIC STROKE. VESSEL TORTUOSITY WAS MODERATE. THE ACCESS VESSEL WAS THE LEFT CCA WITH A DIAMETER OF 6.9MM. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE REPORTED. ADDITIONAL INFORMATION RECEIVED THAT THE CAUSE OF THE LEAK WAS NOT DETERMINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    864744 CELLO BALLOON GUIDE CATHETER CATHETER, PERCUTANEOUS DQY FUJI SYSTEMS CORPORATION 1610090 5200217

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Male