BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VENTRALIGHT ST W/ ECHO

    MDR report key: 10678217 · Received October 14, 2020

    Report

    Report Number
    1213643-2020-09364
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 28, 2020
    Report Date
    October 14, 2020
    Manufacturer
    DAVOL INC., SUB. C.R. BARD, INC.
    Product Code
    FTL
    UDI-DI
    00801741031755
    PMA / PMN Number
    K122436
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    AS REPORTED, THE POSITIONING FRAME OF THE VENTRALIGHT ST W/ ECHO MESH DETACHED DURING PLACEMENT. THE SAMPLE WAS NOT RETURNED FOR EVALUATION. BASED ON THE INFORMATION PROVIDED, AND NOT HAVING THE SAMPLE TO EVALUATE, ROOT CAUSE FOR THE REPORTED EVENT COULD NOT BE DETERMINED; NO CONCLUSION CAN BE MADE. A REVIEW OF THE MANUFACTURING RECORDS WAS PERFORMED AND FOUND THAT THE LOT WAS MANUFACTURED TO SPECIFICATION. TO DATE, THIS IS THE ONLY REPORTED COMPLAINT FROM THIS MANUFACTURING LOT OF (B)(4) UNITS RELEASED FOR DISTRIBUTION IN JULY, 2020. THE INSTRUCTIONS FOR USE (IFU) SUPPLIED WITH THIS DEVICE RECOMMENDS " THE VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM SHOULD BE HYDRATED FOR NO MORE THAN 1-3 SECONDS JUST PRIOR TO LAPAROSCOPIC PLACEMENT. THE VENTRALIGHT ST WITH ECHO PS POSITIONING SYSTEM MUST BE ROLLED IMMEDIATELY AFTER HYDRATION. USING THE INTRODUCER TOOL OR GRASPER ROLL THE VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM PARALLEL TO THE BARD LOGO WITH THE POLYPROPYLENE ON THE OUTSIDE AND BIORESORBABLE COATED SIDE WITH THE ECHO PS ON THE INSIDE. INSERT INTO THE ABDOMEN THROUGH THE RECOMMENDED MINIMUM TROCAR OR TROCAR INCISION SITE. DO NOT FORCE THE DEVICE THROUGH THE TROCAR. IF THE VENTRALIGHT ST MESH WITH ECHO PS POSITIONING SYSTEM WILL NOT EASILY DEPLOY DOWN THE TROCAR, REMOVE THE TROCAR AND INSERT THROUGH THE NEXT LARGEST AVAILABLE SIZE TROCAR OR THROUGH THE TROCAR INCISION SITE AND REINSERT TROCAR. SEE TABLE IN PRODUCT DESCRIPTION SECTION FOR RECOMMENDED MINIMUM TROCAR SIZE." PER THE INSTRUCTIONS-FOR-USE THE RECOMMENDED MINIMUM TROCAR SIZE FOR CAT # 5955680 IS 12MM. SHOULD ADDITIONAL INFORMATION BE PROVIDED, A SUPPLEMENTAL EMDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A LAPAROSCOPIC ABDOMINAL VENTRAL HERNIA REPAIR PROCEDURE ON (B)(6) 2020, VENTRALIGHT ST MESH W/ ECHO POSITIONING SYSTEM (6X8, ELLIPSE) WAS USED. DURING PLACEMENT OF THE MESH THROUGH A 12MM TROCAR, THE ECHO PS BALLOON DETACHED FROM THE MESH AFTER INFLATION. AS REPORTED, THE SURGEON WORKED AROUND THE ISSUE AND WAS ABLE TO FIXATE THE MESH AND THE MESH WAS SUCCESSFULLY IMPLANTED. HOWEVER, AS REPORTED ¿IT CAUSED THE PROCESS TO BECOME MORE DIFFICULT WITH PLACEMENT.¿ THERE WAS NO REPORTED PATIENT INJURY AND THE SURGEON IS AN EXPERIENCED USER OF THE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1144485 VENTRALIGHT ST W/ ECHO SURGICAL MESH FTL DAVOL INC., SUB. C.R. BARD, INC. NA HUEQ0877 00801741031755

    Patients

    Seq Age Sex Outcome Treatment
    1