BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WINCH KYPHOPLASTY BALLOON CATHETER 11G 15MM

    MDR report key: 19881671 · Received August 1, 2024

    Report

    Report Number
    3010899956-2024-00003
    Event Type
    Malfunction
    Date Received
    August 1, 2024
    Date of Event
    June 28, 2024
    Report Date
    May 15, 2025
    Manufacturer
    G21 S.R.L
    Product Code
    NDN
    PMA / PMN Number
    K172214
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    NO OTHER COMPLAINTS CONCERNING THE KIT 900016 BATCH 20240300156, OR COMPLAINT ON THE DEVICE 900027 BATCH 20240100099, HAVE BEEN RECEIVED. THE MOST PROBABLE CAUSES THAT COULD HAVE LED TO THE OCCURRENCE OF THE EVENT DESCRIBED IN THE COMPLAINT ARE AS FOLLOWS: - IT IS POSSIBLE THAT THE PERSONNEL THAT USE THE DEVICE WAS NOT FAMILIAR WITH THE DEVICE PRIOR TO USE. - IT IS POSSIBLE THAT THE DISTAL PART OF THE DEVICE 900027 (BALLOON) MAY NOT HAVE FULLY DEPLOYED FROM THE ACCESS CANNULA PRIOR TO INFLATION. INFLATING THE BALLOON BEFORE IT HAS COMPLETELY EXITED THE ACCESS CANNULA MAY RESULT IN BALLOON FAILURE DUE TO CONTACT BETWEEN THE BALLOON AND ACCESS CANNULA. - IT IS POSSIBLE THAT THE DEVICE CAME IN CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOLS, INCLUDING THE ACCESS CANNULA, STYLET, AND/OR HAND DRILL. BECAUSE THE BALLOON COMPONENT MAY FAIL DUE TO CONTACT WITH BONE SPLINTERS AND/OR SURGICAL TOOLS; - ALTHOUGH THE CUSTOMER STATED THAT THE PRESSURE PROVIDED TO INFLATE THE BALLOON WAS BELOW THE MAXIMUM LEVEL, IT IS POSSIBLE THAT A DEFECT IN THE G21 DIGITAL INFLATION DEVICE ((B)(6)), PRESUMABLY USED IN CONJUNCTION WITH THE BALLOON CATHETER (900027). THE DEFECT COULD HAVE CAUSED THE BALLOON TO BE INFLATED TO A MUCH HIGHER PRESSURE THAN INDICATED ON THE DIGITAL DISPLAY. IT WAS REPORTED THAT THE PATIENT WAS NOT HARMED BY THE MALFUNTION AND THE SURGERY WAS COMPLETED AS INTENDED. THE REVIEW OF THE DFMECA#B002_12 SHOWN THAT THERE IS NO NEED TO RAISE THE RISK OR INSERT A NEW RISK BASED ON THE FOLLOWING CONSIDERATIONS: · THE NUMBER OF DEVICES MANUFACTURED IN THE BATCH 20240100099 IS (B)(4) AND ONLY ONE DEVICE FROM THE BATCH IS INVOLVED IN THIS COMPLAINT. · THIS IS THE ONLY ONE COMPLAINT RECEIVED FOR THIS BATCH · THIS IS THE FOURTH COMPLAINT EVER AND THE FIFTH DEVICE, SINCE PRODUCT 900027 WAS MARKETED IN 2016, FOR THIS TYPE OF FAILURE MODE. · THE OCCURRENCE OF THIS FAILURE MODE FOR THIS BATCH IS (B)(4). · THE OCCURRENCE OF THIS FAILURE MODE RESPECTS THE TOTAL NUMBER OF DEVICES SOLD SINCE PLACING ON THE MARKET IS (B)(4). THE FOLLOWING ACTIONS WERE TAKEN TO CONTROL THE QUALITY OF THIS INCIDENT GIVEN THE RISK AND SAFETY TO THE PATIENT. * A REQUEST ON CONDUCTING TRAINING AND RECORDING THE TRAINING SESSION FOR THE DOCTOR WHO ORIGINATED THE COMPLAINT. * THE CURRENT PRODUCT COMPLAINT EVENTS WILL BE TRACKED FOR TRANDING PURPOSES FOR EFFECTIVE MONITORING TO MEET THE QUALITY PROCEDURES.

    Additional Manufacturer Narrative · 0

    ON 06-AUG-2024, ADDITIONAL TESTS HAVE BEEN PERFORMED BY R&DO MATTEO U. ON THE RETURNED KIT 900016 BATCH 20240300156. THE FOLLOWING TESTS HAVE BEEN PERFORMED: VISUAL INSPECTION: * 900103 NEEDLE USED TO INSERT THE BALLOON HAD NO DEFECTS. * 900027 NOTED YELLOWING OF THE TRANSPARENT SILICONE OF THE BALLOON. NO STRUCTURAL/MECHANICAL DEFECTS. * K05-02919 INSTRUMENT USED TO INFLATE THE BALLOON HAD NO DEFECTS. CONFIRMED BURST PRESSURE TESTING WAS COMPLIANT WITH QUALITY SPECIFICATIONS. IN ADDITION, ON 30-JUL-2024, REMEDIAL TRAINING WAS CONDUSTED BY JPM (B)(6). TO THE STAFF OF G21USA INC AND SURGITECH OWNER HUNTER MULLINS WHO IS THE DISTRIBUTOR WHO ORIGINALLY RECEIVED THE COMPLAINT, TO GO OVER THE APPROPRIATE METHOD OF USING THE PRODUCT WINCH KYPHOPLASTY BALLOON CATHETER 15MM (REF. 900016). THE GENERAL MANAGER CONFIRMED THAT THE DISTRIBUTOR HAS PERFORMED TRAINING FOR ALL REPRESENTATIVE AND CLINICIANS, AND THAT IT IS SATISFACTORY FOR NOW. IT IS THE DISTRIBUTOR'S RESPONSIBILITY TO HOLD ALL THE TRAINING RECORDS.

    Description of Event or Problem · 0

    1. THE SURGEON PERFORMED ROUTINE TASKS IN PREPARING THE PROCEDURE AND 11 GAUGE BALLOON. THE BALLOON WAS INFLATED TO WITHIN ~2-3 CC VOLUME AND UNDER LOW PRESSURES THAT WERE COMPLIANT WITH MAXIMUM LEVELS. UPON DEFLATION OF THE BALLOON, IT BECAME STUCK IN THE VERTEBRAL BODY UPON ATTEMPTED REMOVAL. EVERY EFFORT WAS MADE TO MANIPULATE THE BALLOON AND INSURE IT WAS PROPERLY DEFLATED AND IT STILL WOULD NOT COME OUT FORCING THE SURGEON TO PULL THE SHAFT UNTIL THE DISTAL BALLOON CATHETER BECAME SHEARED OFF INTO THE VERTEBRAL BODY. THE SURGEON THEN FILLED THE REMAINING VERTEBRAL BODY CAVITY WITH V-STEADY BONE CEMENT. 2. THERE WAS NO REPORTED HARM TO THE PATIENT. 3. YES THE PROCEDURE WAS PERFORMED ANYWAY AND THE VOID CONTAINING THE BALLOON WAS ENCAPSULATED AND FILLED WITH V-STEADY CEMENT. 4. NO FURTHER DELAY 5. THE DEVICE IS NOT ABLE TO BE SENT AS IT IS NOW PERMANENTLY IMPLANTED " IT IS STATED THAT THE PATIENT WAS NOT AFFECTED BY THE EVENT AND NO HARM WAS REPORTED. THE DEVICE INVOLVED IN THE COMPLAINT IS NOT AVAILABLE FOR INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1188593 WINCH KYPHOPLASTY BALLOON CATHETER 11G 15MM CEMENT, BONE, VERTEBROPLASTY NDN G21 S.R.L 900027 20240100099

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention