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 Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Low Oxygen Saturation (2477); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/30/2021

Event Type  Injury  

Manufacturer Narrative

Continuation of concomitant products: 990063-020 mapping catheter.

Event Description

It was reported that during a cryo ablation procedure, a cardiac perforation was identified via angiography.The pulmonary vein isolation procedure was aborted due to the patient suffering a cardiac perforation and the patient's unstable vital signs.The patient experienced hypotension from a pericardial effusion which resulted in cardiac tamponade.The physician perform a pericardiocentesis on the patient resulting in stabilization of the of patient's blood pressure, oxygen saturation levels and heart rate.It is unknown which device caused the cardiac perforation.The sheath, mapping catheter and balloon catheter had all advanced into the cardiac chamber.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The patient file showed at least one application was performed with the afapro28 balloon catheter with lot 14625 without any issue on the reported date of the event.The clinical issues (cardiac tamponade, pericardial effusion, perforation, and hypotension) were encountered during the cryo ablation procedure.In conclusion, the reported clinical issues could not be assessed through data analysis.There is no indication of a relation of the adverse event to the performance and malfunction of the product.The physical product has not yet been returned for analysis.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: 12452961
• MDR Text Key: 270799592
• Report Number: 3002648230-2021-00425
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• 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
• Report Date: 10/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010732467
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER.; AFAPRO28 BALLOON CATHETER,
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Weight: 73