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

Model Number 2AF283

Device Problem Gas/Air Leak (2946)

Patient Problems Bacterial Infection (1735); Stroke/CVA (1770); Death (1802); Embolism (1829); Fever (1858); Fistula (1862); Muscle Weakness (1967); Nausea (1970); Vomiting (2144); Loss of consciousness (2418)

Event Date 08/01/2016

Event Type  Death  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.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.The date of death is not available at the time of this report; as there is no indication of specific lot number for patient information.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: ¿atrio-oesophageal fistula complicating cryoballoon which presented with recurrent fever and stroke.¿ nobel medicus.2018; 14(3): 45-50.If information is provided in the future, a supplemental report will be issued.[(b)(4)].

Event Description

The literature publication reported the following patient complications while using a cryoablation balloon catheter: the patient presented to the local hospital with "fever, chills, shivering, sweating, nausea, vomiting, chest pain, elevated while cell count and inflammatory markers." three weeks prior, the patient had an ¿uneventful ad well-tolerated¿ cryoablation procedure.Examination determined that there was a ¿lower respiratory tract infection,¿ and the patient was prescribed medications.Subsequently, the patient traveled to the hospital of the author, and presented with ¿fever, chills, shivering, elevated inflammatory markers, and low platelet counts.¿ the patient was admitted to the hospital due to febrile episodes and was suspected to have an infection.Blood samples were taken, and the patient was started on intravenous antibiotic therapy.The next day the patient developed ¿new onset weakness in the right extremities, which became acutely aphasic with a right hemiplegia.¿ the patient underwent a head computed tomography (ct) which showed a ¿mild hypodensity at the posterior side of left centrum semiovale and the subcortical area of the precentral gyrus.¿ blood cultures that the patient had revealed positive results for streptococcus mitus, streptococcus oralis and capnocytophaga spp.The patient was treated with medications.Ten hours later, a follow up ct scan revealed ¿extensive right cerebral hypodensity and cortical swelling consistent with right parietal infarction, extensive cerebral air emboli and right parenchymal hematoma.¿ gas bubbles in the left ventricle were also seen.The patient then underwent an upper gastric endoscopy which showed a fistula and air bubbles.The patient condition worsened.After discussion with the medical staff and family, the decision was made to purse surgery.The surgery went as planned and the patient was transferred to the intensive care unit (icu).The author noted that although the air embolization was eliminated, and the chest was drained, the patient¿s condition ¿continued to worsen.¿ the patient then developed refractory septic shock leading to death, 24 hours after the surgery.Further follow up did not yet yield any additional information.

• 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8499932
• MDR Text Key: 141477483
• Report Number: 3002648230-2019-00263
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2019
• 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
• Patient Outcome(s): Death; Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR