BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT

    MDR report key: 7211905 · Received January 23, 2018

    Report

    Report Number
    2210968-2018-70397
    Event Type
    Injury
    Date Received
    January 23, 2018
    Report Date
    January 4, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAQ
    PMA / PMN Number
    K946173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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. 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. WERE THE CASES DISCUSSED IN THIS ARTICLE PREVIOUSLY REPORTED TO ETHICON? IF YES, PLEASE PROVIDE A COMPLAINT REFERENCE NUMBER. DOES THE SURGEON BELIEVE THAT ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POST-OPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE DEEP STERNAL WOUND INFECTION, BLEEDING, PERIOPERATIVE MYOCARDIAL INFECTION, SUPERFICIAL STERNAL WOUND INFECTION? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE STAINLESS STEEL, MONOCRYL, VICRYL, SUTURE USED IN THIS PROCEDURE? ARE THE PRODUCT CODE AND LOT NUMBERS AVAILABLE FOR ETHICON DEVICES USED? CITATION: JOURNAL OF CARDIOTHORACIC SURGERY (2015) 10:166. DOI 10.1186/S13019-015-0378-7 - (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED IN JOURNAL ARTICLE ¿REDUCTION IN DEEP STERNAL WOUND INFECTION WITH USE OF A PERISTERNAL CABLE-TIE CLOSURE SYSTEM: A RETROSPECTIVE CASE SERIES ¿RETROSPECTIVE CHART REVIEW STUDY EVALUATED THE INCIDENCE OF DEEP STERNAL WOUND INFECTION (DSWI) ASSOCIATED WITH TWO TECHNIQUES FOR STERNAL CLOSURE. THE PATIENT UNDERWENT STERNAL CLOSURE BETWEEN 07/2010 AND 07/2014 AND MONOFILAMENT WIRE SUTURE WERE PLACED TO COAPT THE MANUBRIUM STERNI AND TO COAPT THE CAUDAL MOST PORTION OF THE CORPUS STERNI. POST OPERATIVELY THE PATIENT MAY HAVE EXPERIENCED DEEP STERNAL WOUND INFECTION, MANAGED BY FORMAL STERNAL DEBRIDEMENT AND PLACEMENT OF NEGATIVE PRESSURE THERAPY DEVICE, WITH SUBSEQUENT MUSCLE FLAP CLOSURE. THE PATIENT POSSIBLY EXPERIENCED STERNAL DEHISCENCE WITH ADDITIONAL PROCEDURE. THE PATIENT MAY HAVE EXPERIENCED RE-EXPLORATION FOR BLEEDING, RE-WIRING AND / OR SUPERFICIAL STERNAL WOUND INFECTION. THE PATIENT POSSIBLY EXPERIENCED PERIOPERATIVE MYOCARDIAL INFARCTION. IN CONCLUSION, THE CABLE-TIE CLOSURE SYSTEM, WHEN USED IN CONJUNCTION WITH WIRE SUTURES, IS A SIMPLE AND RELIABLE METHOD FOR COAPTING THE CORPUS STERNI AFTER MEDIAN STERNOTOMY. THE RESULTS SUGGEST THAT USE OF THE CABLE TIES FOR THIS PURPOSE MAY REDUCE THE RISK OF DSWI COMPARED TO WIRE SUTURES ALONE. ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    56461 SURGICAL STAINLESS STEEL SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE, STEEL GAQ ETHICON INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention