BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AGILE PATENCY SYSTEM

    MDR report key: 1581867 · Received January 13, 2010

    Report

    Report Number
    9710107-2010-00023
    Event Type
    Injury
    Date Received
    January 13, 2010
    Report Date
    January 15, 2010
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K053639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    AGILE CAPSULE IS AN ACCESSORY TO THE PILLCAM VIDEO CAPSULE AND IT'S INTENDED USE IS TO VERIFY ADEQUATE PATENCY OF THE GASTROINTESTINAL TRACT PRIOR TO ADMINISTRATION OF THE PILLCAM VIDEO CAPSULE IN PTS WITH KNOWN OR SUSPECTED STRICTURES. IN THIS CASE, THE X-RAY WHICH WAS OBTAINED AFTER INGESTION FOR THE AGILE CAPSULE WAS MISINTERPRETED AS SHOWING PATENCY OF THE GI TRACT. IN FACT, THE AGILE CAPSULE WAS RETAINED IN THE SMALL BOWEL, AS SEEN AT THE SUBSEQUENT SURGERY. THUS, THE AGILE CAPSULE DID FUNCTION AS DESIGNED. IN ADDITION, IT WAS FOUND THAT THE AGILE CAPSULE USED WAS PAST ITS EXPIRATION DATE. LABELING OF THE AGILE PATENCY SYSTEM CLEARLY STATES THE EXPIRATION DATE OF THE PRODUCT. FURTHERMORE, THIS PT HAD A KNOWN SMALL BOWEL STRICTURE. THIS CONDITION REPRESENTS A CONTRAINDICATION TO THE USE OF THE PILLCAM SB CAPSULE AS DEMONSTRATED IN THE LABELING OF THE PRODUCT.

    Description of Event or Problem · 1

    PHYSICIAN REPORTED WITH THE FOLLOWING INCIDENT: PT WITH CROHN'S DISEASE AND A KNOWN SMALL BOWEL STRICTURE AS DEMONSTRATED BY SBFT. PHYSICIAN PERFORMED PILLCAM SB AFTER ASSESSING PATENCY WITH AGILE. ON ROUTINE X-RAY ON THE DAY AFTER AGILE INGESTION, THE AGILE PATENCY CAPSULE WAS SEEN IN THE LOWER PELVIS. BASED ON THE X-RAY, IT WAS BELIEVED THAT THE AGILE HAD PROBABLY PASSED THE SMALL BOWEL AND WAS IN THE COLON. OTHER IMAGING, LIKE FLUOROSCOPY, WAS NOT DONE AT THE TIME. THE PT UNDERWENT PILLCAM SB ENDOSCOPY. THE CAPSULE WAS FOUND TO BE STUCK IN THE SMALL BOWEL. SHE WAS INITIALLY ASYMPTOMATIC FOR A FEW DAYS. BUT, SHE WAS SUBSEQUENTLY ADMITTED WITH MODERATE PAIN, SHE HAD NOT HAD OBVIOUS OBSTRUCTIVE SYMPTOMS AND EVENTUALLY UNDERWENT LAPAROSCOPIC SURGERY WITH THE FINDING OF A BENIGN ILEAL STRICTURE WITH TWO CAPSULES: THE AGILE CAPSULE WAS 80% INTACT AS WELL AS THE PILLCAM CAPSULE. THE SURGERY WAS PERFORMED 18 DAYS AFTER AGILE INGESTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AGILE PATENCY SYSTEM AGILE PATENCY SYSTEM NEZ GIVEN IMAGING LTD. 2008-07/6955

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R