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 Cardiac Perforation (2513); No Code Available (3191)

Event Date 11/27/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical product(s): arctic front advance® cardiac cryoablation catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the mapping catheter extended out and punctured the lower lobe of the patient's right lung, which began to fill up with blood.The case was aborted with the patient under general anesthesia.Blood was backed up into the endotracheal tube.A bronchoscopy was performed to remove the blood from the patient's lung.It was noted the right inferior pulmonary vein (ripv) was possibly perforated as well.The patient's hospitalization was extended.The patient was stable at the time of the report, but their recovery time was unknown.No further patient complications have been reported as a result of this event.

Event Description

Incoming information indicates the patient recovered.

Manufacturer Narrative

Product event summary: the data files and sheath 4fc12 with lot number 0009925317, were returned and analyzed.The data files showed that at least ten applications were performed with balloon catheter, 2af284 with lot number 14114, without any issue on the date of the event.Visual inspection of the sheath showed the device was full of blood and was intact with no apparent issues.Deflection worked as per specification.The catheter was inserted into the sheath and flush aspiration was done without any issue.Clinical issues were encountered during the case.In conclusion, the clinical issues were unable to be confirmed via data analysis or product analysis.The sheath passed the returned product inspection as per specification.There is no indication of relation of adverse event to the performance and malfunction of the product.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.

• 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: 9427471
• MDR Text Key: 169731786
• Report Number: 3002648230-2019-00823
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000217136
• UDI-Public: 00763000217136
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/24/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009925317
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2019
• Date Manufacturer Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACHIEVE MAPPING CATHETER - 20 MM; ACHIEVE MAPPING CATHETER - 20 MM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR