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

Model Number 4FC12

Device Problem Air Leak (1008)

Patient Problems Air Embolism (1697); Cardiopulmonary Arrest (1765); Paralysis (1997); ST Segment Elevation (2059); Visual Disturbances (2140)

Event Date 01/31/2018

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 a competitor mapping catheter was inserted into a competitor sheath and positioned in the left atria, st elevation occurred, and the patient's heart beat stopped. It was noted that air ingress in the left ventricle and left atrial appendage was observed via fluoroscopy. When right coronary artery angiography was performed, air ingress in the right coronary artery (rca) was also observed. It was noted that when air ingress occurred, the manufacturer¿s sheath was positioned in the right atrium. A thrombus suction catheter was then used to aspirate air from the rca, with an attempt to aspirate air in the left ventricle and left atrial appendage also performed. It was also reported that the patient was unable to flex the left lower and upper limbs. Medications were administered. The patient regained consciousness, and the patient's pulse recovered. Upon physical examination, the patient's paralysis recovered, however, a visual field defect in the left eye was observed. Angiography and magnetic resonance imaging (mri) were subsequently performed. The case was aborted, and the patient was not under general anesthesia. The patient's hospitalization was extended. No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: data files were returned and analyzed. Data files showed that at least 1 application was performed with the balloon catheter on the date of the event with no issues. The device was not returned for investigation/ analysis. If information is provided in the future, a supplemental report will be issued.

Event Description

It was later reported that the patient's paralysis recovered.

• 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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7297244
• MDR Text Key: 100961665
• Report Number: 3002648230-2018-00114
• 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: 03/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 11/10/2019
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 64406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/13/2017
• 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: 02/26/2018 Patient Sequence Number: 1