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 Atrial Flutter (1730); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 01/12/2024

Event Type  Injury  

Manufacturer Narrative

Continuation of d10: product id afapro28 (12850); product type: 0624-arctic front catheter; product id unknown (unknown serial/lot); product type: mapping catheter; product id: non-medtronic unknown; product type: mapping catheter; product id: non-medtronic unknown: product type: radiofrequency (rf) catheter; 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

It was reported that immediately following a cryo ablation procedure, the patient went into left atrial flutter and tachycardia.Mapping the flutter was attempted with the mapping catheter but the image was not clear.The balloon catheter and mapping catheter were then removed from the patient and another manufacturer's mapping catheter was inserted into the sheath which resolved the issue.The atrial flutter was ablated with another manufacturer's radiofrequency (rf) catheter and the right inferior pulmonary vein (ripv) ostium was touched-up.The rf catheter and sheath were removed from the left atrium and placed in the right atrium.Intracardiac echocardiography (ice) was placed back into the patient's heart to determine if there was any effusion following the ablation.The patient's blood pressure began to drop and an effusion was seen on ice.Effusion had not been seen at the beginning of the case and the patient had previously remained stable throughout the case.An anticoagulant antagonist medication was administered and a drain was p laced.Blood was drained and minimal blood pressure support was given.Once the effusion was drained, the patient's blood pressure normalized and the patient became hemodynamically stable.After ten minutes, more blood was drained and then no more effusion was seen on ice.The patient was admitted to the intensive care unit (icu) for two nights for observation.Additional, but minimal, drainage was performed again.The drain was removed and the patient was discharged.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Correction: the product analysis was corrected.No product was returned for visual or functional testing.Patient data files were returned, analyzed, and summarized correctly in the previous regulatory report.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Evaluation code method (fdm/annex b) medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot number 0012040545 was returned and analyzed.The sheath awas visually inspected and functionally test.No anomalies were found.The data files were returned and analyzed.One patient file was received and recorded on the reported date of the event.It showed 22 applications were performed using a balloon catheter identified as afapro28/12850-006.Patient file didn't show any system notice on the reported date of the event.The reported effusion, hypotension, tachycardia, and atrial flutter could not be assessed through data analysis.The issue is not recorded to the data files.In conclusion, the effusion, hypotension, tachycardia, and atrial flutter are not related to the performance or a 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
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 18575101
• MDR Text Key: 333660404
• Report Number: 3002648230-2024-00021
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2024
• 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
• Device Lot Number: 0012040545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2023
• 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): Required Intervention; Hospitalization
• Patient Age: 68 YR
• Patient Sex: Male