MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 REBAR; CATHETER, CONTINUOUS FLUSH

Model Number UNK-NV-REBAR

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

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.

Event Description

Vaidya, n., karmacharya, r.M., vaidya, s., bade, s., bade, s., poudel, k., kandel, g., thapa, p.Massive hemoptysis and pulmonary t hromboembolism in a patient with pulmonary tuberculosis: a therapeutic conundrum managed with bronchial artery embolization.Kathmandu univ med j.20; 4:80 summary: hemoptysis is a crucial entity taking into account its morbidity and mortality.Pulmonary tuberculosis is the leading cause for massive hemoptysis in our part of the world, which if left untreated may be life threatening.We present a case of a 37-year-old male patient with pulmonary tuberculosis with concurrent pulmonary thromboembolism presenting with massive hemoptysis, which was successfully managed with bronchial artery embolization.This case represents that this measure can be a viable therapeutic choice for a patient with a severe lifethreatening hemoptysis, particularly when other treatment options are unavailable or ineffective.Reported events: a 51-year-old patient developed severe pain in posterior part of left chest probably due to ischemia following embolization of dorsal scapular artery.The pain subsided in about 30 minutes following intravenous analgesics.The patient was admitted for two days and was discharged with oral anticoagulant agents to prevent further embolic episodes along with anti-tubercular therapy.Following the procedure, the patient hasn¿t complained of hemoptysis till the current follow-up of two months.

• Brand Name: REBAR
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: glen belmer ; 9775 toledo way; irvine, CA 92618 ; 6122713209
• MDR Report Key: 17299412
• MDR Text Key: 319093106
• Report Number: 2029214-2023-01077
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: NP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/11/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: UNK-NV-REBAR
• Device Catalogue Number: UNK-NV-REBAR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/11/2023
• 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 Age: 51 YR
• Patient Sex: Male