BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT

    MDR report key: 7652508 · Received June 29, 2018

    Report

    Report Number
    2210968-2018-73956
    Event Type
    Injury
    Date Received
    June 29, 2018
    Report Date
    June 8, 2018
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    PMA / PMN Number
    K133356
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 THE ETHICON PRODUCTS INVOLVED CAUSED AND/OR CONTRIBUTED TO THE POSTOPERATIVE COMPLICATIONS DESCRIBED IN THE ARTICLE? DOES THE SURGEON BELIEVE THERE WAS ANY DEFICIENCY WITH THE ETHICON SUTURE PRODUCTS USED IN THIS PROCEDURE? CITATION: RENAL FAILURE, 38:4, 636-642, DOI: 10.3109/0886022X.2016.1150033; PUBLISHED ONLINE: 28 FEB 2016. [(B)(4)].

    Description of Event or Problem · 1

    IT WAS REPORTED VIA JOURNAL ARTICLE: "TITLE: BRACHIOBASILIC FISTULAE: AN UPPER LIMB AUTOLOGOUS OPTION FOR EVERYONE?" AUTHOR: HARRIS HAMEED, EMMA AITKEN, ZEYAD AL-MOASSEB & DAVID KINGSMORE. CITATION: RENAL FAILURE, 38:4, 636-642, DOI: 10.3109/0886022X.2016.1150033; PUBLISHED ONLINE: 28 FEB 2016. THE AIM OF THIS RETROSPECTIVE, PROSPECTIVE STUDY WAS TO EVALUATE THE OUTCOMES AND MORBIDITY ASSOCIATED WITH BRACHIOBASILIC FISTULA (BBF). BETWEEN JANUARY 2010 AND MARCH 2013, 51 WERE CREATED IN 49 PATIENTS (22 MALE AND 27 FEMALE). MEAN PATIENT AGE WAS 57 YEARS (RANGE: 21¿82 YEARS). THE COMPARATIVE COHORT OF AGE AND SEX-MATCHED BCF CONTAINED 50 FISTULAS CREATED OVER THE SAME PERIOD. DURING THE PROCEDURE, THE BASILICA VEIN WAS THEN ANASTOMOSED TO THE BRACHIAL ARTERY IN THE ANTECUBITAL FOSSA USING 6.0 PROLENE SUTURES (SOMERVILLE, NJ). THE VEIN WAS THEN TUNNELLED WITHIN THE SUBCUTANEOUS TISSUE OF THE ANTERIOR UPPER ARM. THE ANASTOMOSIS WAS THEN REFASHIONED USING 6.0 PROLENE SUTURES. ACCESS RELATED COMPLICATIONS INCLUDED RUPTURED FISTULAS REQUIRING LIGATION, VENOUS STENOSIS, CLOTTED FISTULAS, STEAL AND POOR POSTOPERATIVE WOUND HEALING. IT WAS ALSO FOUND THAT PAIN ON CANNULATION AND CHRONIC PAIN WAS SIGNIFICANTLY HIGHER AMONGST PATIENTS WITH BBF (MEAN VISUAL ANALOG PAIN SCORE (VAS) 3.9 AND 2.2, RESPECTIVELY, FOR BBF VERSUS 2.2 AND 1.5 IN THE BCF GROUP; P50.05). IN CONCLUSION, BBF ARE ASSOCIATED WITH A SIGNIFICANT INITIAL OPERATIVE BURDEN AND HIGHER COMPLICATION AND POORER PATENCY RATES THAN BCF. ABOUT ONE-THIRD OF BBF CREATED IN THIS SERIES WERE NEVER USED. GIVEN THE MORBIDITY ASSOCIATED WITH THIS PROCEDURE, CAREFUL CONSIDERATION SHOULD BE GIVEN TO CREATION OF BBF IN PRE-DIALYSIS PATIENTS PARTICULARLY THOSE IN WHOM THE RATE OF DECLINE IN RENAL FUNCTION IS SLOW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    492990 PROLENE POLYPROPYLENE SUTURE UNKNOWN PRODUCT SUTURE, NONABSORBABLE GAW ETHICON INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention