MAUDE Adverse Event Report: GIVEN IMAGING LTD. PILLCAM PATENCY CAPSULE

Model Number PILLCAM PATENCY CAP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Abdominal Pain (1685); Vomiting (2144); Stenosis (2263); Obstruction/Occlusion (2422)

Event Type  Injury  

Event Description

As agile capsule was identified in the projection of the cecum 3 days after ingestion. The pt was asymptomatic at that time and received laxative treatment as preparation for pillcam sb capsule procedure. Then clinical development of the ileus started with abdominal pain and vomiting. In a ct performed the following day the capsule was still intact. Further the ct revealed a suspected longer stenosis throughout the terminal ileum with an appearance of a corresponding ileus of the small intestine. The capsule could still be located in the cecum directly near a clip which had been implanted endoscopically into the cecum. In a ct performed 4 days prior to the injection there were no pathological findings in the intestine. Abdominal x-rays had been performed in the next days. Three days later, the last x-ray located the intact capsule in the sigmoid colon. After intravenous application of a daily dose of 250mg prednisolone the ileus formed back quickly within three days. The pt had been released asymptomatically.

Manufacturer Narrative

Pillcam patency capsule is an accessory to the pillcam video capsule and its 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. Although we don't have info on whether the pt had a history of surgery and expected post-surgical adhesions, it is likely that the capsule was retained due to adhesions. Also such pathologies usually do not evolve in such a time frame.

• Brand Name: PILLCAM PATENCY CAPSULE
• Type of Device: PILLCAM PATENCY CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD.; hermon bldg., new industrial park,; p.o. box 258; yokneam 20692 ; IS 20692
• MDR Report Key: 3308450
• Report Number: 9710107-2013-00218
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K053639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility

Reporter Occupation

• Type of Report: Initial
• Report Date: 08/15/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2013
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Model Number: PILLCAM PATENCY CAP
• Device Catalogue Number: FGS-0109
• Device Lot Number: NOT AVAILABLE
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Invalid Data
• Patient Outcome(s): Hospitalization; Required Intervention