BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 30IN 6-0 D/A C-1 EP

    MDR report key: 17909535 · Received October 10, 2023

    Report

    Report Number
    2210968-2023-07616
    Event Type
    Malfunction
    Date Received
    October 10, 2023
    Date of Event
    September 12, 2023
    Report Date
    December 8, 2023
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031218949
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED VIA: - PLEASE CONFIRM THE QUANTITY OF SUTURE NEEDLE "POP OFF" THAT OCCURRED DURING THIS PROCEDURE. HOW MANY FOR 8706H AND HOW MANY FOR EP8706H? - PLEASE PROVIDE THE SOURCE OR NAME AND TITLE OF THE EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP) THE SCRUB TECH THAT WAS PRESENT IN THE CASE, CARRIE, SAID ¿SEVERAL¿ OF THE TRADITIONAL AND ¿SEVERAL¿ OF THE EVERPOINT NEEDLES POPPED OFF. ALL OF THE SUTURES USED IN THE CASE WERE SENT FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. EVENTS REPORTED VIA: 2210968-2023-07613, 2210968-2023-07614, 2210968-2023-.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/31/2023. H6 COMPONENT CODE: G07002 PENDING EVALUATION OF RETURNED DEVICE. A DEVICE HAS BEEN RECEIVED, HOWEVER CLARIFICATION IS REQUESTED WHETHER THE PRODUCT BELONGS TO THIS COMPLAINT. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: 1. COULD YOU PLEASE CLARIFY IF ALL THE ADDITIONAL DEVICES BELONG TO THIS COMPLAINT? 1A. IF YES, DID A DEVICE MALFUNCTION OCCUR DURING THE SAME PROCEDURE FOR ALL THE RETURNED DEVICES? 2. IF NOT, COULD YOU PLEASE CLARIFY IF THE ADDITIONAL RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION FOR EACH RETURNED DEVICE. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. 5. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO (B)(4) WITH THE UPS, DHL OR FEDEX TRACKER NUMBER. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: COULD YOU PLEASE CLARIFY IF ALL THE ADDITIONAL DEVICES BELONG TO THIS COMPLAINT? COMPLAINT IS ONLY FOR PRODUCT CODES EP8706H AND 8706H. IF YES, DID A DEVICE MALFUNCTION OCCUR DURING THE SAME PROCEDURE FOR ALL THE RETURNED DEVICES? NO. IF NOT, COULD YOU PLEASE CLARIFY IF THE ADDITIONAL RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. NO, JUST COULDN¿T BE SEPARATE. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION FOR EACH RETURNED DEVICE. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. ADDITIONAL PRODUCT DOES NOT BELONG TO ANY COMPLAINT. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO (B)(4) WITH THE UPS, DHL OR FEDEX TRACKER NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT AN IMPELLA INSERTION PROCEDURE ON (B)(6) 2023 AND SUTURE WAS USED. DURING THE PROCEDURE, WHILE SUTURING UNKNOWN TISSUE THE NEEDLE OF TWO SUTURES CODES POPPED OFF. THIS HAPPENED MULTIPLE TIMES THROUGHOUT THE PROCEDURE. NEEDLE WAS NEVER UNACCOUNTED FOR. ADDITIONAL SUTURES WERE USED TO CONTINUE WITH THE PROCEDURE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ADVERSE CONSEQUENCES FOR THE PATIENT. ALL SUTURE USED IN THE CASE IS BEING RETURNED INCLUDING THE AFFECTED SUTURES. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2237957 PRLNE BLU 30IN 6-0 D/A C-1 EP SUTURE, NONABSORBABLE, SYNTHETIC GAW ETHICON INC. TEBCMC 10705031218949

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown