MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

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

Patient Problems Syncope (1610); Dyspnea (1816); High Blood Pressure/ Hypertension (1908); Hypoxia (1918); Pneumonia (2011); Pulmonary Edema (2020); Pulmonary Valve Stenosis (2024); Heart Failure (2206); Stenosis (2263); Respiratory Failure (2484); Low Cardiac Output (2501)

Event Date 05/09/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 990063-020: mapping catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a successful cryo ablation procedure, the patient had an acute onset of shortness of breath and a cough.The patient became hypoxic and went to the emergency room, where he was found to have bilateral pulmonary edema.A left heart catheterization was performed, and abnormal 80% stenosis extending into the left anterior descending artery was noted.A chest x-ray showed abnormal stable patchy airspace disease.A carotid arterial duplex showed abnormal 50% stenosis.Intravenous, oral and intramuscular medication was administered.The patient was hospitalized for a prolonged period.The patient's outcome is unresolved.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: b5, g3.If information is provided in the future, a supplemental report will be issued.

Event Description

The patient is a participant in a clinical study.

Event Description

It was reported the adverse event resolved.

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.

Event Description

Additional information indicates the patient had a right heart catheterization.The coronary artery disease was noted to extend into the circumflex.Mildly abnormal right heart pressures at rest were noted.'normal cardiac' was indicated.Cardiomyopathy with a depressed left ventricular ejection fraction was noted, as well as acute respiratory failure secondary to either heart failure or pneumonia.

Event Description

Incoming information noted that the patient was diagnosed with coronary artery disease, acute respiratory failure, hypertension, hypoxemia, and syncope.The patient had a coronary bypass procedure five days post-cryoablation.

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: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• MDR Report Key: 10085731
• MDR Text Key: 193099696
• Report Number: 3002648230-2020-00294
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/05/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009899354
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 2AF284 BALLOON CATHETER,
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 68