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

Model Number 4FC12

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 11/12/2019

Event Type  Death  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed. The files showed at least ten applications were performed with a non-returned balloon catheter afapro28 with lot number 98536 on the date of the event. System notice # (b)(4). ¿the refrigerant delivery path was obstructed¿ was triggered at the beginning of the ablation phase in application #1 and #2. Subsequent applications were performed without any recorded anomalies. Clinical issues were encountered post procedure. In conclusion, the sheath was not returned for investigation. There is no indication of relation of adverse event to the performance of the cryo device. If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that following a cryo ablation procedure that was completed with cryo, low blood pressure was noted. The physician concluded the patient had a pericardial effusion resulting from cardiac tamponade. The reason for and time of the tamponade is unknown. A pericardiocentesis was performed, successfully increasing the blood pressure, but it did not stop the bleeding. The patient was transferred to cardiac surgery to stop the bleeding and close the tamponade; the bleeding was stopped successfully but the patient became hemodynamically unstable. The patient was transferred to the intensive care unit for monitoring and hemodialysis was performed. The patient passed away during the night.

• 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: 9403145
• MDR Text Key: 168855534
• Report Number: 3002648230-2019-00819
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GR
• 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
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 07/09/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 12965
• 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: 11/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/10/2019
• 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: 12/03/2019 Patient Sequence Number: 1

Treatment

2ACH20 MAPPING CATHETER, AFAPRO28 BALLOON CATHETER