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 Low Blood Pressure/ Hypotension (1914); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 10/25/2021

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, the left atrial appendage was perforated.Prior to removing the balloon catheter from the left atrium, it was noted that the patient's blood pressure was low.Pericardial effusion was identified on the echocardiogram.Pericardiocentesis was performed and the patient was transported to the operation room for surgery to repair the left atrial appendage.The surgery was successful.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: 12814498
• MDR Text Key: 281108914
• Report Number: 3002648230-2021-00523
• Device Sequence Number: 1
• Product Code: DRA
• UDI-Device Identifier: 00763000418052
• UDI-Public: 00763000418052
• 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: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/09/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010818785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2021
• Date Device Manufactured: 09/09/2021
• 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: AFAPRO28 BALLOON CATHETER, 990063-020 MAPPING CATH
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Sex: Male