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 Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/11/2023

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, during the transseptal puncture which was performed under the guidance of int racardiac echocardiography (ice) and fluoroscopy, the sheath and integrated dilator/needle were advanced into the fossa ovalis.After sheath and integrated dilator/needle were repositioned four times, the physician gained access to the left atrium through the patent foramen ovale (pfo).The transseptal system was repositioned a fifth time and the transseptal puncture was completed.The pressure line was removed, and a guidewire was inserted.The guidewire was unable to be advanced into the left superior pulmonary vein (lspv).Under ice guidance, the integrated dilator/needle was advanced over the guidewire wire into the left atrium.It was verified that the integrated dilator/needle was in the left atrium.The sheath was advanced over the integrated dilator/needle.After removing the integrated dilator/needle and the guidewire from the sheath, the sheath was aspirated, and contrast was injected to evaluate positioning.The contrast showed that the sheath was in the aorta.It was further reported that the aorta was perforated, and as a result the sheath was not removed from the aorta to avoid severe bleeding.The physician stated that there was no severe pericardial effusion and pericardiocentesis was not needed.The case was aborted.The sheath was stabilized externally, and the patient was placed under emergent general anesthesia for the transfer to a cardiosurgical center.When the patient arrived at the cardiosurgical center, the patient was stable and had good vital signs.The sheath was surgically removed the aorta and the perforation repaired.The patient's hospitalization was extended.The physician noted that the patient's "overall health status is very good".No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product id: 900304 product type:flexcath cross.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
• 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: 17793961
• MDR Text Key: 323981418
• Report Number: 3002648230-2023-00443
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2023
• 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: 0011660076
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2023
• Date Device Manufactured: 03/10/2023
• 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
• Treatment: SEE H10..
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 58 YR
• Patient Sex: Female