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 Insufficient Information (3190)

Patient Problem Transient Ischemic Attack (2109)

Event Date 04/01/2015

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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age is male/60 years old.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: electromyographic monitoring for prevention of phrenic nerve palsy in second-generation cryoballoon procedures.Circ.Arrhythmia electrophysiol.2015;8(2):303-307.(b)(4).

Event Description

Franceschi fd, koutbi l, gitenay e, et al.Electromyographic monitoring for prevention of phrenic nerve palsy in second-generation cryoballoon procedures.Circ.Arrhythmia electrophysiol.2015;8(2):303-307.Background-electromyography-guided phrenic nerve (pn) monitoring using a catheter positioned in a hepatic vein can aid in preventing phrenic nerve palsy (pnp) during cryoballoon ablation for atrial fibrillation.We wanted to evaluate the feasibility and efficacy of pn monitoring during procedures using second-generation cryoballoons.Methods and results-this study included 140 patients (43 women) in whom pulmonary vein isolation was performed using a second-generation cryoballoon.Electromyography-guided pn monitoring was performed by pacing the right pn at 60 per minute and recording diaphragmatic compound motor action potential (cmap) via a quadripolar catheter positioned in a hepatic vein.If a 30% decrease in cmap amplitude was observed, cryoapplication was discontinued with forced deflation to avoid a pnp.Monitoring was unfeasible in 8 of 140 patients (5.7%), pnp occurred in 1.Stable cmap amplitudes were achieved before ablation in 132 of 140 patients (94.3%).In 18 of 132 patients (13.6%), a 30% decrease in cmap amplitude occurred and cryoablation was discontinued.Each time, recovery of cmap amplitude took <(><<)>60 s.In 9 of 18 cases, a second cryoapplication in the same pulmonary vein was safely performed.We observed no pnp or complication related to electromyography-guided pn monitoring.Conclusions-electromyography-guided pn monitoring using a catheter positioned in a hepatic vein seems feasible and effective to prevent pnp during cryoballoon ablation using second-generation cryoballoon.A journal article was received which contained information regarding multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The literature publication reports the following complications: hematomas, transient ischemic attack (tia), phrenic nerve palsy (pnp).No further patient complications were reported as a result of this event.

Manufacturer Narrative

Event Description

Franceschi fd, koutbi l, gitenay e, et al.Electromyographic monitoring for prevention of phrenic nerve palsy in second-generation cryoballoon procedures.Circ.Arrhythmia electrophysiol.2015;8(2):303-307.Background-electromyography-guided phrenic nerve (pn) monitoring using a catheter positioned in a hepatic vein can aid in preventing phrenic nerve palsy (pnp) during cryoballoon ablation for atrial fibrillation.We wanted to evaluate the feasibility and efficacy of pn monitoring during procedures using second-generation cryoballoons.Methods and results-this study included 140 patients (43 women) in whom pulmonary vein isolation was performed using a second-generation cryoballoon.Electromyography-guided pn monitoring was performed by pacing the right pn at 60 per minute and recording diaphragmatic compound motor action potential (cmap) via a quadripolar catheter positioned in a hepatic vein.If a 30% decrease in cmap amplitude was observed, cryoapplication was discontinued with forced deflation to avoid a pnp.Monitoring was unfeasible in 8 of 140 patients (5.7%), pnp occurred in 1.Stable cmap amplitudes were achieved before ablation in 132 of 140 patients (94.3%).In 18 of 132 patients (13.6%), a 30% decrease in cmap amplitude occurred and cryoablation was discontinued.Each time, recovery of cmap amplitude took <(><<)>60 s.In 9 of 18 cases, a second cryoapplication in the same pulmonary vein was safely performed.We observed no pnp or complication related to electromyography-guided pn monitoring.Conclusions-electromyography-guided pn monitoring using a catheter positioned in a hepatic vein seems feasible and effective to prevent pnp during cryoballoon ablation using second-generation cryoballoon.A journal article was received which contained information regarding ablation sheaths and catheters.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The literature publication reports the following complications: hematomas, transient ischemic attack (tia), phrenic nerve palsy (pnp).No further patient complications were 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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5048212
• MDR Text Key: 24767133
• Report Number: 3002648230-2015-00253
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/06/2015
• 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; Required Intervention
• Patient Age: 00060 YR