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

Model Number UNKNOWN PILLCAM PATENCY CAPSUL

Device Problem Entrapment of Device (1212)

Patient Problems Aspiration/Inhalation (1725); Dyspnea (1816); Radiation Exposure, Unintended (3164)

Event Date 01/09/2020

Event Type  Injury  

Manufacturer Narrative

Title: patency capsule aspiration source intern med, volume 59, 2020 (1071-1073) article number: 7 date of advance publication: 09 january 2020.If information is provided in the future, a supplemental report will be issued.

Event Description

According to literature source of study performed, a patient with anemia who had undergone two(2) abdominal surgeries for colon and gastric cancer, complained of respiratory distress, with a percutaneous arterial oxygen saturation of 90% at room air just after swallowing a patency capsule before endoscopy.Chest radiography and computed tomography revealed that the patency capsule was located within the bronchus intermedius so the patient was admitted for the removal of the patency capsule.The patency capsule was successfully retrieved by flexible bronchoscopy under local anesthesia, wherein the balloon was placed over the capsule and inflated.Subsequently, the catheter was pulled, while thus dragging the capsule with it and preventing damage.The patency capsule was removed seven(70 hours after aspiration, and the patient¿s respiratory symptoms diminished.

Manufacturer Narrative

Additional information: b5, g4.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.

Event Description

According to literature source of study performed (2019), a patient with anemia who had undergone two abdominal surgeries for colon and gastric cancer, complained of respiratory distress, with a percutaneous arterial oxygen saturation of 90% at room air just after swallowing a patency capsule before endoscopy.Chest radiography and computed tomography revealed that the patency capsule was located within the bronchus intermedius so the patient was admitted for the removal of the patency capsule.The patency capsule was successfully retrieved by flexible bronchoscopy under local anesthesia, wherein the balloon was placed over the capsule and inflated.Subsequently, the catheter was pulled, while thus dragging the capsule with it and preventing damage.The patency capsule was removed 7 hours after aspiration, and the patient¿s respiratory symptoms diminished.

• Brand Name: PILLCAM PATENCY
• Type of Device: SYSTEM, IMAGING, GASTROINTESTINAL, WIRELESS, CAPSULE
• Manufacturer (Section D): GIVEN IMAGING LTD., YOQNEAM; yetsira 13 street; yoqneam 20692
• MDR Report Key: 10164481
• MDR Text Key: 195480001
• Report Number: 9710107-2020-00247
• Device Sequence Number: 1
• Product Code: NEZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

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 PATENCY CAPSUL
• Device Catalogue Number: UNKNOWN PILLCAM PATENCY CAPSUL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/01/2020
• Initial Date FDA Received: 06/17/2020
• Supplement Dates Manufacturer Received: 06/30/2020
• Supplement Dates FDA Received: 07/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 77 YR