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 Cardiac Arrest (1762); Death (1802); Great Vessel Perforation (2152); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 01/22/2019

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 pericardial effusion was observed.The balloon catheter was positioned twice, but occlusion was not obtained.Cardiac tamponade then occurred.The case was aborted, and the patient was under general anesthesia.An emergent surgery was then performed as the pericardial drainage was not enough to restore the patient's cardiac function.Surgery then revealed a "wound" in the left superior pulmonary vein (lspv), which is the size of the "balloon nose." the patient experienced cardiac arrest, and subsequently died.

Manufacturer Narrative

(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received confirmed that the left superior pulmonary vein (lspv) was perforated.Additionally, the cause of death was perforation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Additional information received confirmed that the left superior pulmonary vein (lspv) was perforated.Additionally, the cause of death was perforation.

• 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: 8272328
• MDR Text Key: 133909290
• Report Number: 3002648230-2019-00044
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2019

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: 10/28/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 04226
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/28/2019; 01/28/2019
• Supplement Dates FDA Received: 02/20/2019; 02/27/2019
• Date Device Manufactured: 10/30/2018
• 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: 990063-020 MAPPING CATHETER
• Patient Outcome(s): Death; Life Threatening; Required Intervention
• Patient Age: 68 YR