MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ACHIEVE MAPPING CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number 990063-020

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); Fistula (1862); Hematoma (1884); Low Blood Pressure/ Hypotension (1914); Unspecified Infection (1930); Aortic Dissection (2491); Pericardial Effusion (3271)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

Medtronic cryocath 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.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.Referenced article: pericardial-esophageal fistula complicating cryoballoon ablation for refractory atrial fibrillation.Heart rhythm case reports.2017;3:2¿6.Http://dx.Doi.Org/10.1016/j.Hrcr.2016.12.002.

Event Description

The literature publication reports the following patient complication while using a cardiac cryoablation catheter and/or a mapping catheter: there was one (1) patient who experienced ¿crushing chest pain¿ ten days after the cryoablation procedure.A computed tomography (ct) of the chest was done, which showed pericardial effusion and pneumopericardium.While the patient was being transferred to a higher level of care facility, the patient developed low blood pressure which was stabilized with fluids and medication.Antibiotics were also given, due to the suspected infection.The next day the patient was taken to surgery.During the procedure, a ¿gross amount of fibrinous exudate¿ was found surrounding and on the surface of the heart.This was cleansed and irrigated, but there still was ¿blood-tinged fluid¿ noted within the pericardium.The patient was placed on cardiopulmonary bypass, so that the physician could get a ¿full-inspection¿ of the heart.An ultrasound was performed and a hematoma was confirmed, as well as a ¿dissection flap.¿ once the patient was placed on bypass, the heart was ¿lifted up¿ and there was an ¿obvious¿ tear noted in the posterior pericardium, which was close to another tear in the esophagus.Both tears were repaired.The article indicated that ¿cultures obtained during the surgery were positive for multiple organisms including lactobacillus species, strep-tococcus species, saccharomyces species, candida species, and mycobacterium avium,¿ and the patient was given antimicrobial, antibiotics, and antifungals.One week later, the esophagram showed a ¿small, contained esophageal leak.¿ a procedure was done to repair the leak.One week after the patient was discharged; the esophagram showed it was healing.The patient completed four weeks of antimicrobial treatments; however, the treatment for one of the infection-types was not tolerated well by the patient.The patient ¿has done well¿ and is free from any more infections.The status/location of the catheters is unknown.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: ACHIEVE MAPPING CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 6387344
• MDR Text Key: 69360919
• Report Number: 3002648230-2017-00116
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102588
• 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,Followup
• Report Date: 02/24/2017

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: Physician
• Device Model Number: 990063-020
• Device Catalogue Number: 990063-020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/24/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 02/24/2017
• Supplement Dates FDA Received: 10/02/2017
• 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
• Treatment: ARCTIC FRONT CARDIAC CRYOABLATION CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 70 YR