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 Problems Foreign Body In Patient (2687); Unintended Radiation Exposure (4565)

Event Date 06/01/2005

Event Type  Injury  

Event Description

According to the literature source of study performed between june 2005 and december 2015.The patency capsule is designed to evaluate the patency of the small bowel before administration of small-bowel capsule endoscopy (sbce) in patients at high risk of retention.The utilization of a patency capsule may be associated with a risk of symptomatic retention, but very few cases have been reported to date.The aim of our study was to describe our experience with this rare complication of a patency capsule.In total, 20 symptomatic cases of retention out of 1615 (1.2 %) patency capsule tests were identified; in one patient, the patency capsule was retained in the esophagus, in the rest, the capsule was detected in the small bowel resulting in abdominal pain or small-bowel obstruction.One patient (5 %) had a history of uc and is status post colectomy with ileostomy.A plain film after the patency ingestion showed the patency capsule performed last (b)(6) 2020.4 days ((b)(6)) later another film was performed which the patency capsule was not identified.A small bowel series performed in (b)(6) 2020 and nothing obviously abnormal.No retained patency capsule identified and ct was in (b)(6) 2021.Regarding the enteroscopy previously mentioned (prior to patency capsule): had endoscopy above and below: the approach from below made it to the anastomotic site, but the approach from above didn't make it to the anastomosis (a portion of the bowel remained unseen).Regarding post cholecystectomy: the patient had some discomfort post cholecystectomy; the suspected retained patency capsule component(s) was not thought to have been driving the discomfort, although the possibility of it contributing cannot be entirely excluded.There seems to have been no discrete metallic rfid tag present in the area.All other patients resolved spontaneously or after corticosteroid therapy.

Manufacturer Narrative

Title: symptomatic retention of the patency capsule: a multicenter real life case series source: kopylov uri et al.Symptomatic retention of the patency capsule¿ endoscopy international open 2016; 04: e964¿e969.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but photos were available for evaluation.In one patient, the patency capsule was retained in the esophagus, in the rest, the capsule was detected in the small bowel resulting in abdominal pain or small-bowel obstruction.Ct scans were received and the retention was confirmed.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: 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.Patients should be made aware of the signs and symptoms of bowel obstruction (abdominal pain, nausea, vomiting, and distention) and be advised to contact their physician should these symptoms occur anytime between capsule ingestion and documented excretion.Patients should also be informed that surgical intervention may be required if obstruction were to occur.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: 13117833
• MDR Text Key: 282963167
• Report Number: 9710107-2021-00510
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Reporter Country Code: IS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/26/2022

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: Health Professional
• Device Model Number: UNKNOWN PILLCAM
• Device Catalogue Number: UNKNOWN PILLCAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/26/2022
• 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
• Patient Outcome(s): Required Intervention