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

Model Number 4FC12

Device Problem Gas/Air Leak (2946)

Patient Problems Air Embolism (1697); Bradycardia (1751); Ventricular Fibrillation (2130); Heart Block (4444)

Event Date 04/14/2021

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, air ingress occurred when the sheath was inserted into the left atrium or when contrast media was introduced into the left inferior pulmonary vein.Following ablation of the left superior pulmonary vein, bradycardia occurred.Right ventricular pacing was performed.Then, st elevation occurred and progressed to atrioventricular block and ventricular fibrillation (vf).The vf stopped.A coronary angiography was performed and air was noted.An attempt was made to collect the air, but it was absorbed into the patient's body.The st elevation recovered.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 4fc12 sheath with lot number 0010506797 was returned and analyzed.Visual inspection of the sheath showed the device shaft was intact with no apparent issue.Using the sentinel blackbelt leak tester, the sheath passed the test and the shaft and valve were leak tight with no apparent issue.The aspiration/flushing test did not show any air passing through the tube or expelling from the sheath distal tip.The hemostatic valve was leak tight.Deflection worked per specification.In conclusion, the reported clinical issues for embolism, st elevation, heart block, and arrhythmia were encountered during the procedure and cannot be assessed through testing.The air ingress issue was not confirmed through testing and the sheath passed the returned product inspection as per specification.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: 11716847
• MDR Text Key: 251456280
• Report Number: 3002648230-2021-00196
• 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: 05/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/07/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010506797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2021
• Date Manufacturer Received: 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AFAPRO28 BALLOON CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention