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

Model Number 4FC12

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Cardiac Tamponade (2226); Shock, Surgical (2267); Pericardial Effusion (3271)

Event Date 09/08/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.The baseline gender/age of the patients represented in the article is male/(b)(6) years old.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.Referenced article: ¿management of cardiac tamponade in catheter ablation of atrial fibrillation: single-centre 15 year experience on 5222 procedures.¿ europace (2017) 0, 1¿7.Doi:10.1093/europace/eux307.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications while using a cryoablation balloon catheter/sheath catheter: there were reports of cardiac tamponade, shock, pericardial effusions, as a result of the ablation procedure.Treatment included pericardiocentesis with drains placed, blood infusions, and open chest surgery for two patients.There was one patient who experienced cardiac tamponade, was treated, and medication had been started on the first day post-procedure, and on the second day post-procedure.However, atrial fibrillation (af) recurred and was ¿resistant¿ to cardioversion.Then on the eighth day post-procedure, the patient had a cerebral infarction, but recovered within one week.There was also one patient who on the thirteenth day post-procedure, presented to the emergency room with chest discomfort, fever, ¿elevated inflammatory reaction,¿ with pericardial effusion, and ¿delayed¿ tamponade.Medication was given, and the effusion disappeared.However, the issue recurred as soon as the medication was stopped on the 36th day post-procedure, medication was given and gradually tapered off; which resolved the issue.In addition, there was one patient who died on the fourth day post-procedure, ¿related to the tamponade,¿ which according to the author was from ¿massive brain oedema.¿ this patient, on the third say post-procedure, had a ¿brain stem infarction.¿ medication had been started on the second post-procedural day.Of importance, for this patient, sinus rhythm was ¿maintained¿ after the procedure.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with manufacturers/methods/unique lot numbers.The status/location of the catheters is unknown.No further patient complications have been reported as a result of this event.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7138392
• MDR Text Key: 95502517
• Report Number: 3002648230-2017-00704
• 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,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2017
• 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: 11/27/2017
• 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: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR