BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET

    MDR report key: 8217828 · Received January 4, 2019

    Report

    Report Number
    1820334-2019-00014
    Event Type
    Injury
    Date Received
    January 4, 2019
    Date of Event
    November 15, 2018
    Report Date
    March 1, 2019
    Manufacturer
    COOK INC
    Product Code
    FGE
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BLANK FIELDS ON THIS FORM INDICATE THE INFORMATION IS UNCHANGED, UNKNOWN OR UNAVAILABLE. PATIENT CODES: NO CODE AVAILABLE (3191): ADDITIONAL JEJUNOSTOMY PERFORMED AS AN ALTERNATIVE TO THE ORIGINAL GASTROSTOMY PROCEDURE. THE ORIGINAL PATIENT CODES REPORTED WERE CODES 3191 (NO CODE AVAILABLE - PROCEDURE REQUIRED TO REMOVE COMPLAINT DEVICE), 1932 (INFLAMMATION), AND 2045 (RESPIRATORY DISTRESS). THESE CODES STILL APPLY TO THIS EVENT AND ARE NOT TO BE OVERWRITTEN. THE NEW PATIENT CODES WERE ADDED IN ADDITION TO THE ORIGINAL CODES. THE EVENT IS CURRENTLY UNDER INVESTIGATION. A FOLLOW-UP REPORT WILL BE SUBMITTED UPON RECEIPT OF ADDITIONAL INFORMATION OR COMPLETION OF THE INVESTIGATION. THIS REPORT IS REQUIRED BY THE FDA UNDER 21 CFR PART 803. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR CONTRIBUTED TO; OR IS LIKELY TO CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF A MALFUNCTION OCCURRED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION ¿ EVALUATION. A REVIEW OF THE INSTRUCTIONS FOR USE (IFU), MANUFACTURING INSTRUCTIONS, AND QUALITY CONTROL OF THE DEVICE WAS 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 REVIEW OF THE INSTRUCTIONS FOR USE (IFU) RECOMMEND THAT THE BOLSTERS OF THE DEVICE SHOULD BE EVALUATED PERIODICALLY, AND THE TENSION CAN BE ADJUSTED IF NEEDED AFTER PLACEMENT. BASED ON THE INFORMATION PROVIDED, NO PRODUCT RETURNED AND THE RESULTS OF OUR INVESTIGATION, THE ROOT CAUSE COULD NOT BE TRACED TO THE DEVICE. 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. THIS REPORT IS BASED ON UNCONFIRMED INFORMATION SUBMITTED BY OTHERS. NEITHER THE SUBMISSION OF THIS REPORT NOR ANY STATEMENT MADE IN IT IS INTENDED TO BE AN ADMISSION THAT ANY COOK DEVICE IS DEFECTIVE OR MALFUNCTIONED; THAT A DEATH OR SERIOUS INJURY OCCURRED; OR THAT ANY COOK DEVICE CAUSED OR 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

    ADDITIONAL INFORMATION WAS RECEIVED ON 11JAN2019. THIS INFORMATION STATED THE PATIENT HAD TONGUE CANCER AS A PRE-EXISTING CONDITION. THE PATIENT UNDERWENT A GASTROSTOMY ON (B)(6) 2018, THE PATIENT WAS DISCHARGED. BETWEEN (B)(6) 2018, THE ENTUIT SUTURE ANCHOR WAS LOCATED IN THE WALL OF THE SKIN AND NOT THE STOMACH, LEADING TO A GASTRIC LEAK. ON (B)(6) 2019, PURULENT DRAINAGE WAS PERFORMED UNDER COMPUTED TOMOGRAPHY (CT). ON (B)(6) 2018, CUTANEOUS NECROSIS WAS OBSERVED, AND REMOVAL OF THE SUTURE ANCHOR WAS ATTEMPTED BY SURGERY. THE PATIENT WAS NOTED TO BE "VERY ALGETIC" AT THIS TIME. UNDER GENERAL ANESTHESIA, THE PATIENT SUFFERED RESPIRATORY DISTRESS DUE TO THE PATIENT'S ORAL LICHENOID LESION. AN URGENT TRACHEOSTOMY WAS PERFORMED. ON 03DEC2018, A JEJUNOSTOMY WAS PERFORMED TO REPLACE THE GASTROSTOMY. IT WAS REPORTED A SECTION OF THE COMPLAINT DEVICE DID NOT REMAIN INSIDE THE PATIENT'S BODY. NO OTHER ADDITIONAL PROCEDURES OR ADVERSE EFFECTS HAVE BEEN REPORTED FOR THIS INCIDENT.

    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. (B)(4). 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 USED FOR A GASTROSTOMY PROCEDURE. AFTER THREE DAYS, THE ANCHOR WAS FOUND TO HAVE MOVED TO THE SKIN FROM THE STOMACH, CAUSING A GASTRIC LEAK. INFLAMMATION AND PERCUTANEOUS INJURY WERE OBSERVED AT THE ANCHOR SITE. DUE TO PATIENT PAIN, THE SURGEONS ATTEMPTED TO REMOVE THE ANCHOR UNDER GENERAL ANESTHESIA. NO INFORMATION HAS BEEN PROVIDED REGARDING THE FINAL REMOVAL OF THE COMPLAINT DEVICE. DURING THE ATTEMPTED REMOVAL OF THE DEVICE IT WAS REPORTED THAT THE PATIENT'S ORAL LICHENOID LESION CAUSED THE PATIENT RESPIRATORY DISTRESS AND THE SURGEONS WERE REQUIRED TO PERFORM A TRACHEOTOMY. ADDITIONAL INFORMATION REGARDING THE PATIENT OUTCOME HAS BEEN REQUESTED, BUT IS CURRENTLY UNAVAILABLE. ADDITIONAL INFORMATION REGARDING THE EVENT AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12739 ENTUIT SECURE GASTROINTESTINAL SUTURE ANCHOR SET FGE CATHETER, BILIARY, DIAGNOSTIC FGE COOK INC N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other| R