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 Chest Pain (1776); Hematoma (1884); Hemorrhage/Bleeding (1888); Pain (1994); Cardiac Perforation (2513)

Event Date 04/24/2018

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, a perforation occurred when the mapping catheter was fully deployed into the left atrium.The case was completed with cryo.Post-operatively, the patient had severe chest and back pain.An echocardiogram was ordered to ensure there was no effusion or tamponade.There was no fluid noted in the pericardial space.Blood pressure and pulse were noted to be stable without cause for concern.A ct angiogram was ordered, and it revealed an active arterial bleed at the level of the left inferior pulmonary vein (lipv) in front of the descending aorta.A drain was placed due to the hematoma and the active bleed.The patient was transferred to the intensive care unit and back to the ward.The patient remains in the hospital.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product analysis: data files were returned and analyzed.Data files showed 7 applications were performed with a balloon catheter on the date of the event with no system notice.In conclusion, the physical device was not returned for analysis or investigation.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: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7528711
• MDR Text Key: 108719481
• Report Number: 3002648230-2018-00326
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/12/2020
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Device Lot Number: 25510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/23/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/14/2018
• 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: 2ACH20 MAPPING CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention