BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN

    MDR report key: 22385961 · Received July 2, 2025

    Report

    Report Number
    2210968-2025-07793
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    October 11, 2024
    Report Date
    July 2, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAT
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    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. ATTEMPTS ARE BEING MADE TO OBTAIN THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. DOES THE SURGEON BELIEVE THAT ANY OF THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? WHICH SPECIFIC ETHICON PRODUCTS HAVE BEEN USED DURING THE PROCEDURES (PRODUCT CODE, LOT NUMBER)? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH ANY OF THE ETHICON PRODUCTS USED IN THIS PROCEDURE? IF SO, PLEASE PROVIDE DETAILS. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. PATIENT DEMOGRAPHICS? THIS REPORT IS RELATED TO A JOURNAL ARTICLE; THEREFORE, NO PRODUCT WILL BE RETURNED FOR ANALYSIS AND THE BATCH HISTORY RECORDS CANNOT BE REVIEWED AS THE LOT NUMBER HAS NOT BEEN PROVIDED. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED. D4: UDI: AS THE CATALOG/MODEL NUMBER WAS NOT PROVIDED, THE (01) GTIN IS NOT AVAILABLE. CITATION: JACC CASE REP. 2025 MAR 19;30(6 PT 1):102835. HTTPS://DOI.ORG/10.1016/J.JACCAS.2024.102835. EPUB 2025 JAN 8. PMID: 40118603; PMCID: PMC12011144.

    Description of Event or Problem · 0

    TITLE: INAPPROPRIATE S-ICD SHOCK RELATED TO REEL SYNDROME. THE AIM OF THIS STUDY IS TO PRESENT A CASE OF A 37-YEAR-OLD MAN WHO WAS ADMITTED TO INSTITUTION FOLLOWING SUCCESSFUL RESUSCITATION FROM EXERCISE INDUCED VENTRICULAR FIBRILLATION. WHO ALSO HAS A REEL SYNDROME OCCURRING 1 MONTH AFTER SUBCUTANEOUS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR INSERTION WITH NO KNOWN RISK FACTORS FOR LEAD MACRODISLODGMENT. ETHIBOND (ETH) WAS USED TO ANCHORED THE XIPHOID INCISION TO THE FASCIA. REPORTED COMPLICATIONS: ETHIBOND (ETH) (N=1; 37-YEAR-OLD, MALE). INAPPROPRIATELY TREATED NOISE TREATMENT: NOT REPORTED. INAPPROPRIATELY TREATED OVERSENSING TREATMENT: NOT REPORTED. REVEALED RETRACTION OF THE LEAD REELED AROUND THE PG ALONG ITS TRANSVERSE AXIS TREATMENT: NOT REPORTED. ETHIBOND (ETH) (N=1; 37-YEAR OLD, MALE) 2 FAILED SUTURES LEADING TO REEL SYNDROME TREATMENT: NOT REPORTED. IN CONCLUSION, TWIDDLER¿S SYNDROME IS DEFINED AS THE RETRACTION OF THE LEAD DUE TO ROTATION OF THE PG ON ITS LONGITUDINAL AXIS. MOREOVER, IN RATCHET SYNDROME, THE LEAD APPEARS WRAPPED AROUND THE PG, SIMILAR TO REEL SYNDROME, BUT ONLY THE LEAD IS INVOLVED. IN THIS CASE, THE LEAD WAS RETRACTED WITH COILING AROUND THE GENERATOR, WITH SUTURE FAILURE STRONGLY SUGGESTING REEL SYNDROME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9106 ETHIBOND EXTRA & EXCEL POLYESTER SUTURE UNKNOWN SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE GAT ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Male Other