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

Model Number 4FC12

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

Patient Problems Air Embolism (1697); ST Segment Elevation (2059); Cardiogenic Shock (2262)

Event Date 12/26/2018

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, when the balloon catheter was inserted into the sheath and then inserted into the left atrium, st elevation occurred. Back-up pacing was performed to resolve the st elevation. Additionally, air ingress was observed in the aorta. A thrombosis aspiration catheter was used to aspirate the air in the aorta. A coronary angiography was subsequently performed and an air embolism was observed in the right coronary artery, which was also aspirated with resolve. Air was observed in the left auricle, and ¿pig tail¿ was used to aspirate the air. The case was then aborted while the patient was not under general anesthesia. It was also reported that the patient also experienced cardiogenic shock. It was further reported the physician believes there is a high possibility that when the sheath was inserted into the left atrium and dilator removed, air ingress occurred. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Event summary: visual inspection of sheath 4fc12/ 85233- 082 showed the device was intact with no apparent issues. Several flushes and aspirations were performed without issues while the balloon catheter was inserted. Aspiration/flushing test did not show any air passing through the tube or expelled from the sheath distal tip. Multiple aspirations / injections were performed without air bubbles or leaks through the hemostatic valve when a test balloon catheter was introduced through the sheath. Hemostatic valve was leak tight. There is no sufficient evidence that the devices potentially caused these adverse events. In conclusion, this is a clinical issue (st elevation, air embolism) were encountered during the procedure. The reported air ingress issue was not confirmed through the testing for the returned sheath. The sheath passed the product inspection as per specification. There is no indication of relation of adverse event to the performance of the sheath. 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8261615
• MDR Text Key: 133559335
• Report Number: 3002648230-2019-00040
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 02/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 10/28/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 85233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/26/2018
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 01/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/18/2019 Patient Sequence Number: 1