BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PILLCAM SB CAPSULE

    MDR report key: 1667062 · Received April 15, 2010

    Report

    Report Number
    9710107-2010-00220
    Event Type
    Injury
    Date Received
    April 15, 2010
    Report Date
    April 15, 2010
    Manufacturer
    GIVEN IMAGING LTD.
    Product Code
    NEZ
    PMA / PMN Number
    K070475
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INCIDENT HAS BEEN PUBLISHED IN CLINICAL GASTROENTEROLOGY AND HEPATOLOGY VOL. 8, NO. 4 2010; E37-E38. THE INVESTIGATORS CONCLUDED THAT: "SMALL BOWEL VIDEO CAPSULE ENDOSCOPY HAS IMPROVED THE DIAGNOSTIC EVAL OF THE GASTROINTESTINAL TRACT. IDENTIFICATION OF APPROPRIATE CANDIDATES FOR TESTING AND RECOGNITION OF CONTRAINDICATIONS ARE CRITICAL IN THE SAFE USE OF THIS TECHNOLOGY. PTS WITH KNOWN ORAL-PHARYNGEAL DYSPHAGIA REQUIRING SMALL BOWEL VIDEO CAPSULE ENDOSCOPY SHOULD UNDERGO ENDOSCOPIC ASSISTED CAPSULE DEPLOYMENT." GIVEN IMAGING LABELING EXPLICITLY INDICATES IN USER MANUAL UNDER CONTRAINDICATION SECTION, THAT PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE IN PTS WITH SWALLOWING DISORDERS. HERE ARE THE CONTRAINDICATION AS INDICATED IN THE USER MANUAL. THE PILLCAM SB CAPSULES ARE CONTRAINDICATED FOR USE UNDER THE FOLLOWING CONDITIONS: IN PTS WITH KNOWN OR SUSPECTED GASTROINTESTINAL OBSTRUCTION, STRICTURES, OR FISTULAS BASED ON THE CLINICAL PICTURE OR PREPROCEDURE TESTING AND PROFILE. IN PTS WITH CARDIAC PACEMAKERS OR OTHER IMPLANTED ELECTROMEDICAL DEVICES. IN PTS WITH SWALLOWING DISORDERS.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION: A (B) (6) MAN PRESENTED WITH URINARY SEPSIS TO HOSPITAL. UPPER GASTROINTESTINAL ENDOSCOPY AND COLONOSCOPY DID NOT REVEAL A SOURCE OF GASTROINTESTINAL BLOOD LOSS. BECAUSE OF PERSISTENT TRANSFUSION-DEPENDENT ANEMIA WITH OBSCURE GASTROINTESTINAL BLOOD LOSS. AFTER 2 MINUTES FOLLOWING INGESTION, HE DEVELOPED A MILD NONPRODUCTIVE COUGH THAT LASTED FOR 20 SECONDS. HE THEN REPORTED A SENSATION OF CAPSULE IMPACTION IN THE BACK OF HIS THROAT. THE INITIAL IMAGES CLEARLY REVEALED THE CAPSULE WITHIN THE TRACHEA AT THE LEVEL OF THE CARINA. THE PT DENIED ANY DYSPNEA AND HAD NO EVIDENCE OF STRIDOR, WITH AN OXYGEN SATURATION OF 98% ON ROOM AIR. AN IMMEDIATE PULMONOLOGY CONSULTATION WAS OBTAINED, AND AN EMERGENCY BRONCHOSCOPY REVEALED AN IMPACTED VIDEO CAPSULE IN THE RIGHT MAIN-STEM BRONCHUS. BY USING A RETRIEVAL BASKET, THE CAPSULE WAS EXTRACTED FROM THE BRONCHIAL TREE AFTER SEVERAL ATTEMPTS. ANALYSIS OF THE VIDEO CAPSULE DATA REVEALED MULTIPLE SPONTANEOUS EJECTIONS OF THE CAPSULE FROM THE TRACHEA, BUT ULTIMATELY THE CAPSULE BECAME IMPACTED IN THE BRONCHIAL TREE. THE PT RECOVERED UNEVENTFULLY AND UNDERWENT SUBSEQUENT SWALLOW EVAL FOR ORAL-PHARYNGEAL DYSPHAGIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PILLCAM SB CAPSULE PILLCAM SB CAPSULE NEZ GIVEN IMAGING LTD. NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention