MAUDE Adverse Event Report: GIVEN IMAGING LTD., YOQNEAM BRAVO; ELECTRODE, PH, STOMACH

Model Number UNK-BRAVO

Device Problems Break (1069); Insufficient Information (3190)

Patient Problems Airway Obstruction (1699); Aspiration/Inhalation (1725); Foreign Body In Patient (2687); Unspecified Tissue Injury (4559)

Event Date 11/30/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The patient attorney alleged that during the ph testing with the bravo reflux capsule, the bravo capsule went defective and patient experienced injury.

Event Description

As per the medical records, the patient was undergoing evaluation of gastroesophageal reflux disease (gerd) with an upper endoscopy (egd)/ph probe being placed.The bravo capsule with delivery system was introduced through the mouth and advanced into the esophagus, such that the bravo ph capsule was positioned 32 cm from the incisors.The bravo capsule was deployed and attached to the esophageal mucosa.The probe did not deploy properly and was later on observed to be in the oropharynx.The patient took a breath and we suspect she aspirated the probe into the trachea.Endoscopy was utilized for probe placement and diagnostic evaluation.Patient had significant coughing so intubated with 8 ett.The patient was intubated by an anthologist, received phenobarbital and succinylcholine pta [prior to arrival] and had an transferred to the hospital.The patients blood pressure was low 94/68 during transport.The patient was admitted to icu for management of acute respiratory failure and mechanical ventilation.The chest x-ray showed partially radio dense object within left mainstem bronchus distally.The foreign body was removed by rigid bronchoscopy with no complications.The patient is stable post removal of foreign body, has been extubated and weaned to 4l nasal cannula.The patient was experiencing occasional bradycardia, isolated hypertension.The lab reports were remarkable except for metabolic acidosis.

Manufacturer Narrative

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.

Manufacturer Narrative

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: BRAVO
• Type of Device: ELECTRODE, PH, STOMACH
• 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: 13625252
• MDR Text Key: 286350524
• Report Number: 9710107-2022-00041
• Device Sequence Number: 1
• Product Code: FFT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: UNK-BRAVO
• Device Catalogue Number: UNK-BRAVO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/18/2022
• Was Device Evaluated by Manufacturer?: No
• 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): Hospitalization; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 57 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White