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); 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.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• 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
• 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,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

• 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
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/24/2019
• 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: 01/02/2020 Patient Sequence Number: 1