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); Exsanguination (1841); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Blood Loss (2597); No Code Available (3191); Pericardial Effusion (3271)

Event Date 07/06/2018

Event Type  Death  

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, a patient died.During the procedure, the patient began to become hypotensive and a pericardial effusion with cardiac tamponade was confirmed via ultrasound.A pericardial puncture was performed to drain the blood and the patient's chest was opened to assist with stopping the bleed.The case was aborted while the patient was under general anesthesia.The patient was put on a bypass pump and the left superior pulmonary vein (lspv) was repaired via open heart surgery.It was further indicated that the patient died due to blood loss.

Manufacturer Narrative

Event summary: during the procedure, the patient began to become hypotensive and a pericardial effusion with cardiac tamponade was confirmed via ultrasound.A pericardial puncture was performed to drain the blood and the patient's chest was opened to assist with stopping the bleed.The case was aborted while the patient was under general anesthesia.The patient was put on a bypass pump and the left superior pulmonary vein (lspv) was repaired via open heart surgery.It was further indicated that the patient expired due to blood loss.The sheath was not returned for investigation.There is no indication of the reported adverse events being related to a manufacturing defect or performance of the device.In conclusion, this is a case related to multiple clinical adverse events (bleeding, cardiac tamponade, pericardial effusion, hypotension) and patient expiration.The case was aborted under general anesthesia.The reported adverse events could not be related to the performance of the cryoablation devices.The sheath was not returned for investigation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7732429
• MDR Text Key: 115457232
• Report Number: 3002648230-2018-00506
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000043773
• UDI-Public: 00763000043773
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/22/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 74766
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2018
• Initial Date FDA Received: 07/30/2018
• Supplement Dates Manufacturer Received: 08/21/2018; 08/08/2018
• Supplement Dates FDA Received: 09/13/2018; 10/05/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/23/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 2AF284 CATHETER, 990063-020 MAPPING CATHETER
• Patient Outcome(s): Death; Life Threatening; Required Intervention