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 Problem Non specific EKG/ECG Changes (1817)

Event Date 04/15/2022

Event Type  Injury  

Event Description

It was reported that during a cryo ablation procedure, a st elevation was observed on the electrocardiogram (ecg) after the sheath was advanced into the left atrium.A right coronary artery contrast study showed that some of the images were not visible.A catheter was used for suction as consideration for the risk of clots or air but no air or clots were found.The st recovered and the entire coronary artery was imaged without issue when the right and left coronary angiographies were performed again.The case was aborted midway through the procedure due to the amount of time to perform the angiogram.The patient was not under anesthesia and it is unknown if the patient was hospitalized or hospitalization extended. no further patient complications have been reported as a result of this event.

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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14463130
• MDR Text Key: 292510573
• Report Number: 3002648230-2022-00210
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Other
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/11/2024
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0011007671
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/10/2022
• Date Device Manufactured: 01/11/2022
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Male