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); Perforation (2001); Pericardial Effusion (3271)

Event Date 05/05/2022

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 990063-020, mapping catheter.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, once all four pulmonary veins (pv) had been treated, the patients blood pressure dropped suddenly.A pericardial effusion was observed via echocardiogram.A pericardiocentesis was performed to drain the blood but it was not successful.The patient was taken to the operating room for further intervention and in doing this, a perforation was discovered in the left atrial appendage.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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14402694
• MDR Text Key: 292511947
• Report Number: 3002648230-2022-00205
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/21/2024
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011069197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2022
• Date Device Manufactured: 02/21/2022
• 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
• Patient Outcome(s): Life Threatening; Required Intervention