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

Model Number 4FC12

Device Problems Gas/Air Leak (2946); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Air Embolism (1697); Non specific EKG/ECG Changes (1817)

Event Date 10/23/2020

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, st elevation occurred after the sheath was inserted into the patient.An air embolism was observed in the left atrium.The valve of the sheath was broken.The case was aborted.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the 4fc12 sheath with lot 0010314844 and returned electronic photo were analyzed.Visual examination of the provided photo shows a deformation of the sheath.It is not possible to assess the leaking issue or air ingress through the photo of hemostasis valve, as it needs to be tested to check any potential leak through the silicone valve.The opening of the valve shown in the photo could be related to the retraction of the catheter from sheath.Visual inspection of the sheath showed the shaft was intact with no apparent issues.Performance testing with sentinel blackbelt leak tester revealed the pressure decay was in an acceptable range.The shaft and valve were leak tight with no apparent issues.The flush and air aspiration/ingress issue was not reproduced.Several flushes and aspirations were performed without issues while a test balloon catheter was inserted.There was no blockage along the shaft and the shaft and side port was leak tight.St elevation may occur in the absence of a product malfunction.Product anomalies in the catheter and sheath may also lead to air ingress or st elevation, though no anomaly was seen with the sheath.The cause of the adverse event could not be determined for this event.In conclusion, a clinical issue (st elevation) occurred during the case.The reported air ingress and hemostatic valve issue were not confirmed through testing.There is no indication of a relation of the adverse event to the performance and malfunction of the product.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: 10855245
• MDR Text Key: 216835342
• Report Number: 3002648230-2020-00599
• 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: 12/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/25/2022
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010314844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2020
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening