MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Low Blood Pressure/ Hypotension (1914); ST Segment Elevation (2059); Exit Block (2628); No Code Available (3191)

Event Date 12/09/2019

Event Type  Injury  

Manufacturer Narrative

The data files were returned and analyzed.The data files showed that at least eight applications were performed with balloon catheter afapro28 with lot number 98927 without any issue on the date of the event.In conclusion, the air ingress and clinical issues which were encountered during the procedure which could not be assessed via data analysis.The analysis of the physical product is pending.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, st elevation and hypotension were observed.The procedure was paused and an angiography was performed, where a coronary spasm was observed in the right coronary artery (rca).Medications were administered when atrioventricular (av) block was temporarily developed.Air was then observed in the aorta and was aspirated.The st elevation resolved, but the rca spasm remained.Further medications were administered and the procedure began again.The st elevation returned and resolved by air aspiration and medications.The case was completed with cryo.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the flexcath advance sheath, 4fc12 with lot 9925327, was returned and analyzed.Visual inspection of the sheath showed the device was intact with no apparent issue.Air ingress was reproduced during the aspiration test when the test catheter was introduced through the sheath.Functional testing of the sheath confirmed the hemostatic valve was leaking.It is suspected that the valve disk is torn.A clinical issue was encountered during the procedure.In conclusion, clinical issues (hearth block, hypotension and st elevation, vasopasm) occurred during procedure.The clinical issues could not be confirmed via product analysis.The reported issue of air ingress was confirmed through testing.The sheath failed the returned product inspection due to the suspected torn hemostatic valve disk.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.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: b2.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: 9540546
• MDR Text Key: 185359784
• Report Number: 3002648230-2020-00003
• 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,Followup
• Report Date: 03/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0009925327
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Date Manufacturer Received: 02/06/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention