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 Heart Failure/Congestive Heart Failure (4446); Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

This information is based entirely on journal literature.Medtronic was made aware of this event through a search of literature publications.This event occurred outside the us.Patient information is limited due to confidentiality concerns.The event only occurred with one patient but specific details on the patient were not provided.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: heart failure caused by iatrogenic atrial septal defect after cryoballoon ablation for atrial fibrillation.Journal of cardiology cases.2021.24;303¿306.Doi.Org/10.1016/j.Jccase.2021.05.007.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed that contained information regarding cryoballoon ablation.The article reports a patient who underwent cryoballoon ablation.During the procedure of cryoballoon ablation, a single transseptal puncture was performed and a deflectable sheath and a second sheath were used with a circular mapping catheter and crossed the interatrial septum via the same puncture site.Approximately five months later, the patient was readmitted because of heart failure, recurrence of paroxysmal atrial fibrillation (af), and atrial flutter.Transesophageal echocardiogram (tee) showed a large iatrogenic atrial septal defect (iasd) and right-to-left shunt in the systolic and left-to-right shunt in the diastolic.Enlargement of the right ventricle was also observed, which caused annular dilatation as well as tethering of the tricuspid valve leaflets; hence, a moderate tricuspid regurgitation (tr) was observed.After optimal medical therapy for heart failure, elevation of pulmonary artery wedge pressure, mean pulmonary artery pressure, and pulmonary to systemic blood flow ratio was revealed.A second radiofrequency catheter ablation (rfca) was performed seven months after the first session and tee showed persistent iasd with a bidirectional shunt.Eleven months after the first ablation, the patient was again readmitted because of heart failure, recurrence of paroxysmal af, and atrial tachycardia.Persistent iasd with bidi rectional shunt remained.Therefore, a percutaneous transcatheter closer was performed because heart failure could not be controlled by medication.After the additional third catheter ablation for re-isolation of the right pulmonary vein, defragmentation of the left atrium, and superior vena cava isolation, the iasd was closed.Heart failure was controlled with a decrement of right atrial and ventricular size, and improvement of tr (from severe to mild).Mitral regurgitation also improved from moderate to mild, and there was no shunt at the interatrial septum.The status/disposition of the sheath and catheter is unknown.No further patient complications have been reported as a result of this event.Further follow up did not yet yield any additional information.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 13156011
• MDR Text Key: 285698312
• Report Number: 3002648230-2022-00001
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/19/2021
• 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
• Patient Age: 83 YR
• Patient Sex: Male
• Patient Race: Asian