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)

Event Date 11/14/2019

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 990063-020 mapping catheter.Product event summary: the data files were returned and analyzed.The files showed system notice # (b)(4) ¿the refrigerant delivery path was obstructed¿ was received on the date of the event.Clinical issues (perforation, hypotension, and bleeding) were encountered during the procedure.In conclusion, the sheath was not returned for investigation.There is no indication of relation of adverse event to the performance of the cryo device.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 mapping catheter had difficulties being inserted into the vein.It was maneuvered around and the balloon catheter was inflated.It was then indicated that the mapping catheter was not in the correct area and the balloon was deflated.It was then placed in the branch of the left inferior pulmonary vein (lipv) and inflation began again.The patient's blood pressure then dropped quickly.The ablation was stopped.Drainage was performed followed by intubation, a transfusion and a thoracotomy.A perforation was confirmed.The perforation was sutured and the bleeding stopped.The patient was sent to the intensive care unit and is currently stable.The case was aborted.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: 9402200
• MDR Text Key: 168850381
• Report Number: 3002648230-2019-00817
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

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: 07/24/2021
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 32137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2019
• Initial Date FDA Received: 12/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2019
• 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: 2AF284 BALLOON CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention