BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    MDR report key: 8549082 · Received April 25, 2019

    Report

    Report Number
    1820334-2019-00978
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    June 7, 2019
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: IMPLANT/EXPLANT DATES PROVIDED ON (B)(6) 2019. INVESTIGATION ¿ EVALUATION. A REVIEW OF THE COMPLAINT HISTORY, INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WERE CONDUCTED DURING THE INVESTIGATION. THE COMPLAINT DEVICE WAS NOT RETURNED; THEREFORE, NO PHYSICAL EXAMINATIONS COULD BE PERFORMED. HOWEVER, A DOCUMENT BASED INVESTIGATION EVALUATION WAS PERFORMED. THERE IS NO EVIDENCE TO SUGGEST THE PRODUCT WAS NOT MADE TO SPECIFICATIONS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; ACCORDINGLY, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. A SEARCH OF ALL LOTS PROVIDED TO THE CUSTOMER DURING THE RELEVANT TIMEFRAME COULD NOT NARROW DOWN THE POTENTIAL LOT. IT SHOULD BE NOTED THERE WERE NO OTHER REPORTED COMPLAINTS FOR THESE LOT NUMBERS. THE DEVICE IS SHIPPED WITH INSTRUCTION FOR USE (IFU) WHICH NOTES: "THE GASTROPEXY BOLSTER SHOULD CONTACT THE SKIN BUT NOT CREATE ANY VISIBLE SKIN INDENTATION WHEN AT OPTIMAL TENSION. " COOK RECEIVED A COMPLAINT FOR A SIMILAR PRODUCT EXPERIENCING A SIMILAR FAILURE MODE IN COMPLAINT (B)(4) (MEDWATCH REPORT # 1820334-2019-00014). NO DEVICE WAS RETURNED TO BE INVESTIGATED, BUT THE INVESTIGATION CONCLUDED THAT THE EVENT WAS POSSIBLY DUE TO THE PATIENT¿S CONDITION AND THE PHYSICIAN PULLING THE SUTURE TOO TIGHT, CAUSING THE MIGRATION. BECAUSE OF THE SIMILARITIES IN REPORTED DEVICE AND FAILURE, IT IS LIKELY THAT THE TWO EVENTS HAVE A SIMILAR CAUSE. BASED ON THE INFORMATION PROVIDED, THE EXAMINATION OF THE RETURNED PRODUCT, AND THE RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE COULD NOT BE ESTABLISHED. IT IS POSSIBLE THAT THE PATIENT'S ANATOMY AND CONDITION COULD HAVE CAUSED THE ISSUE, BUT AT THIS TIME CANNOT BE CONFIRMED. THE APPROPRIATE PERSONNEL HAVE BEEN NOTIFIED. PER THE QUALITY ENGINEERING RISK ASSESSMENT NO FURTHER ACTION IS REQUIRED. COOK WILL CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803 AND IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT CONTAINED HEREIN IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED, THAT A DEATH OR SERIOUS INJURY OCCURRED, NOR THAT ANY COOK DEVICE CAUSED, CONTRIBUTED TO, OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

    Additional Manufacturer Narrative · 1

    PMA/510(K) #: K152524. THIS REPORT INCLUDES INFORMATION KNOWN AT THIS TIME. A FOLLOW UP REPORT WILL BE SUBMITTED SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED AN ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET WAS DEPLOYED DURING A G TUBE PLACEMENT. AS REPORTED, "THE ANCHOR SET HUB IS EMBEDDED INTO THE SKIN OF THE PATIENT, ANCHORS HAVE BEEN IN FOR A FEW WEEKS." IT IS CURRENTLY UNKNOWN IF ADDITIONAL INTERVENTION WAS PERFORMED ON THE PATIENT. IMAGES OF THE DEVICE IN SITU WERE PROVIDED CONFIRM THE CUSTOMER TESTIMONY, AND TO AID IN THE INVESTIGATION. ADDITIONAL INFORMATION REGARDING DEVICE MAINTENANCE, EVENT DATE, PATIENT CONDITION AND DETAILS REGARDING PATIENT OUTCOME HAVE BEEN REQUESTED. TO DATE, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341847 ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Other