MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 15 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-015

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Dyspnea (1816); Inflammation (1932); ST Segment Elevation (2059); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/01/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: arctic front advance cardiac cryoablation catheter 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.Please see spreadsheet/pdf for the two patients referenced in the article with cryoballoon procedures.Of note, multiple patients/multiple methods/multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers/methods/manufacturers.The overall baseline gender characteristics is male; the age of the patients was 64 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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿midterm outcomes of catheter ablation for atrial fibrillation in patients with cardiac tamponade.¿ journal of arrhythmia.2019; 35:109¿120.Doi: 10.1002/joa3.12127.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the use of a cryoballoon ablation catheter system.There were patients who experienced cardiac tamponade.Of note, multiple patients, multiple methods, and multiple manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.In one patient, cardiac tamponade occurred immediately after pulmonary vein isolation by cryoballoon and pericardiocentesis was performed; pericarditis occurred two days after catheter ablation and medications were administered.Then the pericarditis resolved, the patient was discharged.However, 33 days after catheter ablation, the patient experienced new-onset shortness of breath and presented to the emergency department.Increased pericardial fluid and inflow blockage was seen on the echo-cardiogram.The patient was diagnosed with ¿recurrent cardiac tamponade¿ and a repeat pericardiocentesis was performed.It was also noted, that st elevation on electrocardiogram (ecg) and increased serum c-reactive protein levels supported the diagnosis of recurrent pericarditis.There was also a patient with cardiac tamponade, which required pericardiocentesis.The status/location of the cryoballoon catheter system is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• Brand Name: ACHIEVE MAPPING CATHETER - 15 MM
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 9913667
• MDR Text Key: 188333278
• Report Number: 3002648230-2020-00196
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102588
• 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: 04/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 990063-015
• Device Catalogue Number: 990063-015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/16/2020
• Initial Date FDA Received: 04/01/2020
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 64 YR