MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM UNKNOWN PILLCAM; SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C

Model Number UNKNOWN PILLCAM

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, the patency capsule was retained.The patient has a history of uc and is status post colectomy with ileostomy.After the colectomy, there was volvulus of small bowel and peritonitis.A portion of small bowel was removed.In about 2019/early 2020 there was some gi bleeding suspected to be related to the small bowel anastamosis.Deep enteroscopy was attempted from both above and below, but a portion of the sb was not accessible and remained unseen.There was interest in performing a procedure to visualize this portion.A patency capsule was ingesting (probably at about early 2020) and at the anticipated plain film the patency capsule seemed to be projecting at/about the area of the sb anastamosis.As such, procedure was not given.More recently the patient had a cholecystectomy.A ct scan wound up being performed after the cholecystectomy, and a retained foreign body was seen in the area of the sb anastomosis, suspected to be remnants of the patency capsule.There seems to have been no discrete metallic rfid tag present in the area.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but ct pictures were available for evaluation.Visual inspection noted the capsule was retained in small bowel.It was reported that the capsule remained in the patient longer than expected.The reported issue was confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: there is a risk of retention for obscure bleeding to be 1.5%, for suspected crohn's disease to be 1.4%, for known crohn's the risk is higher at 5% and for neoplastic lesions the rate of retention is 2.1% as compared to healthy volunteers.To verify passage of the capsule from the gi tract, an abdominal x-ray may be obtained at the discretion of the physician.The capsule can be removed using medical, endoscopic or surgical intervention.Patients with suspected or known intestinal strictures may be at increased risk for bowel obstruction due to impaction of the intact patency capsule at the site of the narrowing or stricture, particularly during the first 1-2 days after capsule administration.Should this occur, patients may require bowel decompression until the capsule disintegrates or surgical intervention, if symptoms persist.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: UNKNOWN PILLCAM
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, C
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer (Section G): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692 ; IS 20692
• Manufacturer Contact: amy beeman ; 161 cheshire lane, suite 100; plymouth, MN 55441 ; 7632104064
• MDR Report Key: 13266047
• MDR Text Key: 284965768
• Report Number: 9710107-2022-00009
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/30/2021
• Initial Date FDA Received: 01/17/2022
• Supplement Dates Manufacturer Received: 02/15/2022
• Supplement Dates FDA Received: 03/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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