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 Hematoma (1884); Vascular System (Circulation), Impaired (2572); Pseudoaneurysm (2605); Pericardial Effusion (3271)

Event Date 01/01/2020

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.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 70 years old.The baseline weight of the patients involved is 64 kgs.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: limited efficacy of a figure-of-eight suture for hemostasis after cryoballoon atrial fibrillation ablation with uninterrupted oral anticoagulants.J cardiol (2020), https://doi.Org/10.1016/j.Jjcc.2020.01.012.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complication during the use of a cryoballoon ablation catheter and sheath.There were two (2) patients who experienced pericardial effusions; however, no sign of cardiac tamponade was observed, and they did not require a pericardiocentesis.There were 31 patients with bleeding at the puncture site; out of this group there were two (2) patients with ¿major¿ bleeding.In addition, there were two (2) patients who had pseudoaneurysms; one required surgical intervention and a blood transfusion, and the other one was treated with manual compression and an injection of thrombin.These occurred at six and seven days after the procedure, respectively.Of note, multiple patients/methods/manufacturers were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The status/location of the cryoballoon catheter and sheath 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.

Manufacturer Narrative

This information is based on the subsequent follow up information obtained.All information provided is included in this report.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.

Event Description

Additional information was obtained through follow up with the author who indicated that none of the events in the article were related to cryoablation products.The effusion occurred using non-cryoablation products.No further information was provided.

• 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
• MDR Report Key: 9831179
• MDR Text Key: 188331457
• Report Number: 3002648230-2020-00158
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/03/2020
• Initial Date FDA Received: 03/13/2020
• Supplement Dates Manufacturer Received: 03/20/2020
• Supplement Dates FDA Received: 04/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 70 YR
• Patient Weight: 64