MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Dyspnea (1816); Hemoptysis (1887); Ulceration (2116); Ulcer (2274); Chest Tightness/Pressure (2463); Blood Loss (2597)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: ¿life-threatening massive hemoptysis after cryoablation for atrial fibrillation.¿ j bronchology interv pulmonol.2017 sep 14.Doi: 10.1097/lbr.0000000000000417.

Event Description

The literature publication reports the following patient complications while using a cryoablation balloon.A patient presented one month post-ablation procedure with chest pressure, bleeding from the nose, and ¿recurrent¿ hemoptysis.The patient also stated that there was worsening ¿exertional dyspnea¿ since the ablation procedure.Of note, the patient had presented to the emergency room (er) one week prior with similar complaints revealed no abnormalities.Upon admission to the hospital, the patient developed ¿severe¿ bleeding from the nose, which was treated and the patient had ¿temporary hemostasis.¿ later the same day, the patient had more bleeding from the nose and ¿massive hemoptysis causing severe respiratory compromise during intubation.¿ the patient then underwent emergency tests and active bleeding, clots were seen.A ¿massive¿ transfusion was initiated.The patient¿s hemoptysis was resolved.The patient had a repeat bronchoscopy performed which showed an area of ¿ulceration,¿ which was missed due to the blood obstructing the view.The author indicated that the ulcer ¿most likely¿ resulted from the ¿cryoablation-induced bronchial injury.¿ the patient was dis charged and remained asymptomatic.Two months later, the patient underwent a follow-up bronchoscopy and it appeared that the ulcer was ¿healing.¿ the status/location of the cryoballoon is unknown.No further patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• 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: 6954898
• MDR Text Key: 89497954
• Report Number: 3002648230-2017-00564
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2017
• 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; Life Threatening; Required Intervention
• Patient Age: 59 YR