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

Model Number 4FC12

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Perforation (2513)

Event Date 05/30/2023

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, difficulty was encountered due to patient tortuosity in the venous system when advancing the sheath, dilator, and guidewire into the right atrium (ra).There was further difficulty when performing the transseptal puncture and when advancing the integrated dilator/needle, sheath, and guidewire into the left atrium (la).After considerable manipulation, it was confirmed on fluoroscopy and intracardiac echocardiography (ice) that the septum was crossed.The balloon catheter was advanced into the la and the attempt to cannulate one of the left pulmonary veins (pv) with the mapping catheter was unsuccessful.The physician surmised that the patient's anatomy was abnormal and chose to remove the balloon catheter and replace the mapping catheter with another manufacturer's device.While trying to map the la, the devices "fell out" and into the ra.The physician was unable to advance the sheath and catheter back into the la and decided to perform the transseptal puncture again.The sheath, integrated dilator/needle, and guidewire were reinserted and difficulty advancing into the la was encountered again.It was determined by the physician that during the repeat transeptal puncture, the sheath, integrated dilator/needle, and guidewire "had somehow ended up in the pericardial space." there was concern that removing the sheath would cause a massive pericardial effusion and after further discussion with cardiac surgery, the physician elected to abort the case while the patient was under general anesthesia.The patient was transferred to the cardiovascular operating room to have the sheath removed and any damage repaired.The patient's hospitalization was extended.It was further reported that the patient was recovering and doing well after surgery to remove sheath.No further patient complications have been reported as a result of this event.

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.

• 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 17042778
• MDR Text Key: 316383219
• Report Number: 3002648230-2023-00279
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011707319
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/30/2023
• Date Device Manufactured: 04/03/2023
• 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 Outcome(s): Required Intervention; Hospitalization; Life Threatening