BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROPLEGE (KIT)

    MDR report key: 22579431 · Received July 23, 2025

    Report

    Report Number
    3031571797-2025-00001
    Event Type
    Malfunction
    Date Received
    July 23, 2025
    Date of Event
    June 24, 2025
    Report Date
    September 11, 2025
    Manufacturer
    ENABLECV, INC
    Product Code
    DWF
    PMA / PMN Number
    K120780
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11/ H3: PRODUCT EVALUATION FINDINGS - THE DEVICE WAS RETURNED FOR EVALUATION AND IN THE PRODUCT EVALUATION, THE REPORTED COMPLAINT OF BALLOON RUPTURE WAS CONFIRMED. A HOLE WAS PRESENT IN THE BALLOON. BLOOD WAS PRESENT INSIDE THE BALLOON AND STOPCOCK. NO MATERIAL WAS FOUND TO BE MISSING FROM THE BALLOON. H11 ADDITIONAL MANUFACTURER NARRATIVE- BASED ON THE CURRENT INFORMATION PROVIDED IN COMMUNICATIONS, USER ERROR WHILE USING THE DEVICE IS SUSPECTED, BUT WILL BE REVIEWED IN THE ONGOING INVESTIGATION. THE MANUFACTURING TEAM REVIEWED THE TWO POTENTIALLY IMPACTED LOTS - THE DEVICE HISTORY RECORD CONTAINED NO RELATED NONCONFORMANCE OR DEVIATION TO THE REPORTED DEFECT. NO EVIDENCE OF A MANUFACTURING DEFECT HAS BEEN FOUND. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY ONCE THE EVALUATION HAS BEEN COMPLETED. ENABLECV (A SUBSIDIARY OF EDWARDS LIFESCIENCES) WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Additional Manufacturer Narrative · 0

    B4, G3, G6, H2, AND H6 UPDATED WITH ADDITIONAL INFORMATION/ FOLLOW UP DETAILS. NO ADDITIONAL PRODUCT EVALUATION FINDINGS ARE AVAILABLE. MITIGATIONS ARE IN PLACE AT THE SUPPLIER. THE COMPLAINT OF RUPTURED BALLOON WAS CONFIRMED THROUGH PRODUCT EVALUATION. LABELLING/ IFU/ RISK DOCUMENTATION ARE CONSIDERED ADEQUATE. BASED ON THE AVAILABLE INFORMATION, OFF LABEL USE/ MISUSE OF THE PRODUCT IS SUSPECTED AS THE SALES REPRESENTATIVE REPORTED IT TOOK 1.55 CC (1.55 ML) TO INFLATE THE BALLOON. THE INSTRUCTIONS FOR USE CLEARLY STATE "WARNING: DO NOT EXCEED MAXIMUM INFLATION VOLUME OF 1.4 ML AS BALLOON BURST MAY OCCUR" AS WELL AS "WARNING: OVERINFLATION MAY RESULT IN INJURY TO THE CORONARY SINUS." THUS, THE MOST LIKELY CAUSE OF THE ADVERSE EVENT IS EXPECTED TO BE THE MISUSE OF THE DEVICE IN OVERINFLATING THE BALLOON. HOWEVER, IS A POSSIBILITY THAT OTHER FORCES OR MANIPULATION OF THE A BALLOON DURING PREP/ USE MAY HAVE LED TO SUCH A FAILURE. NO EVIDENCE OF AN ECV OR SUPPLIER MANUFACTURING NONCONFORMANCE HAS BEEN FOUND. ENABLECV (A SUBSIDIARY OF EDWARDS LIFESCIENCES) WILL CONTINUE TO REVIEW AND MONITOR ALL REPORTED EVENTS. TRENDS ARE MONITORED ON A MONTHLY BASIS AND IF ACTION IS REQUIRED, APPROPRIATE INVESTIGATION WILL BE PERFORMED.

    Description of Event or Problem · 0

    THE PR9 THAT WAS PLACED WITHOUT INCIDENT HAD ITS BALLOON BURST ABOUT 45 MINUTES OR SO INTO THE CASE. VOLUME IT TOOK TO INFLATE THE BALLOON WAS 1.5CC. CARDIOPLEGIA WAS DELIVERED SUCCESSFULLY VIA PR9 AT LEAST ONCE. THERE WAS A LOSS OF WAVEFORM, ANESTHESIA TRIED DEFLATING BALLOON AND NOTICED BLOOD BACK IN THE SYRINGE. THEY PULLED THE CATHETER OUT PRIOR TO THE END OF THE CASE. ADDITIONAL INFORMATION- NO REPRESENTATIVE COVERED THE CASE. TRAINING WAS PERFORMED FOR THE STAFF - OR MOST OF THE STAFF AND ONE WHO WAS TRAINED HELPED OUT DURING PLACEMENT. BALLOON HELD THE VOLUME FOR AT LEAST 45 MINUTES PER THE PHYSICIAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    25622 PROPLEGE (KIT) EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE DWF ENABLECV, INC PR9

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown