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 Hematoma (1884); Pain (1994)

Event Date 09/19/2021

Event Type  Injury  

Event Description

It was reported that post-operatively to a cryo ablation procedure, the patient experienced pain at the access site.The patient was hospitalized as a result of a hematoma which was confirmed through a computerized tomography (ct) scan.Compressions were performed and medications were administered.The patient recovered and was discharged from the hospital.The patient is a participant in a clinical study.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: 13863628
• MDR Text Key: 287805620
• Report Number: 3002648230-2022-00108
• 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,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2023
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 0010706107
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/07/2022
• Date Device Manufactured: 06/09/2021
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 50 KG