MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER - 20 MM; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

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

Patient Problems Stroke/CVA (1770); Paresis (1998); Cardiac Perforation (2513)

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.Patient information is limited due to confidentiality concerns.The overall baseline gender characteristics is male; the age of the patients was approximately 60 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot/serial numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.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: ¿comparison of outcomes using the first and second generation cryoballoon to treat atrial fibrillation.¿ heart lung circ.2020 mar;29(3):452-459.Doi: 10.1016/j.Hlc.2019.03.017.Epub 2019 apr 9.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, and a mapping catheter.There were 15 patients who experienced transient phrenic nerve palsy (pnp); all of which fully recovered during the procedure.There were also six (6) patients who experienced pnp which lasted past the procedure, but all had resolved within 12 months.There were also two patients who experienced gastroparesis; one resolved within three months of the procedure; and one of unknown treatment/resolution.One patient had a small perforation of the left atrium, with a trace pericardial fluid.This patient remained stable, was watched overnight, and was cleared to be discharged the next day.One patient had a left occipital stroke one day post-procedure for cryoablation and typical flutter; with no mention of any residual effects.One patient had a lung resection, due to pulmonary venous infarction, which after imaging was ¿thought to be lung cancer.¿ of note, multiple patients 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/mapping catheter 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

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/physician who indicated that the adverse events were related to the cryoballoon.The perforation of the "left atrial is a known complication of left-sided structural procedures." no further info rmation was provided.

• Brand Name: ACHIEVE MAPPING CATHETER - 20 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
• MDR Report Key: 10007788
• MDR Text Key: 194616076
• Report Number: 3002648230-2020-00249
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• PMA/PMN Number: K102588
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

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: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/21/2020
• Initial Date FDA Received: 04/28/2020
• Supplement Dates Manufacturer Received: 04/28/2020
• Supplement Dates FDA Received: 05/15/2020
• 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; Life Threatening; Required Intervention
• Patient Age: 60 YR