MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN GIVEN IMAGING PRODUCT

Model Number UNKNOWN GIVEN IMAGING PRODUCT

Device Problem Entrapment of Device (1212)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 10/18/2018

Event Type  Injury  

Manufacturer Narrative

Title: premature dissolution of the agile patency device: implications for capsule endoscopy: wray n., healy a.Mcalindon m., 2019, frontline gastroenterology source: received 09/27/2018 revised (b)(6) 2018 accepted (b)(6) 2018 published online first 10/27/2018.If information is provided in the future, a supplemental report will be issued.(b)(4).

Event Description

According to literature source of study performed (june 2017 and march 2018), there was a premature dissolution of the patency capsule occurred in 5 of 307 patients.It was mentioned that the patency capsule was recognized by the detection of persistent radiofrequency signal.However, radiological imaging had failed to identify the patency device, prompting a careful search for the radiofrequency tag on the ct scout film.The radiofrequency signal at 1400h, 30 hours after swallowing the patency capsule was still registered.The ct scout film was performed at 1600h to identify the level at which to target the limited ct scan, but it failed to reveal any evidence of a patency capsule and the patient was returned to the endoscopy unit with the suggestion that the capsule had passed in the 2-hour interval between scans.The patient denied that this had occurred, and the radiofrequency signal was still evident.Review of the scout film suggested that one of four radio-opaque markers thought to be sterilization clips was, in fact, the radiofrequency tag.The tag was difficult to detect because of an oblique lie making it appear smaller than it should be 13×3 mm size and there was a confusion with intra abdominal or other metallic fragments.The patency capsule would occasionally remain intact in the small bowel 30¿36 hours post ingestion in the absence of small bowel strictures.The patency capsule was used to predict small bowel luminal patency and avoid the risk of subsequent retention of capsule endoscopes.This event caused false-positive (suggesting a stricture) and false-negative (suggesting luminal patency) studies.Premature dissolution of the patency capsule occurred in 1.3% of devices, which may explain unexpected capsule retention.

• Brand Name: UNKNOWN GIVEN IMAGING PRODUCT
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 8911820
• MDR Text Key: 156907488
• Report Number: 9710107-2019-00377
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: UNKNOWN GIVEN IMAGING PRODUCT
• Device Catalogue Number: UNKNOWN GIVEN IMAGING PRODUCT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2019
• Initial Date FDA Received: 08/20/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention