MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problems Device Dislodged or Dislocated (2923); Positioning Problem (3009)

Patient Problems Pneumothorax (2012); Cardiac Tamponade (2226)

Event Date 06/01/2015

Event Type  Injury  

Event Description

Miyazaki sd, hachiya h, taniguchi h, et al.Prospective evaluation of bilateral diaphragmatic electromyograms during cryoballoon ablation of atrial fibrillation.Journal of cardiovascular electrophysiology.2015;26(6):622-628.Bilateral diaphragmatic cmaps during cryoablation background left phrenic nerve injury (pni) can occur during cryoballoon ablation of the left pulmonary veins (pvs).This study aimed to evaluate the feasibility of monitoring the bilateral phrenic nerve function during cryoballoon ablation of atrial fibrillation (af).Methods fifty consecutive paroxysmal af patients undergoing cryoballoon ablation using one 28-mm second-generation balloon were prospectively enrolled.Bilateral diaphragmatic compound motor action potentials (cmaps) were obtained from modified surface electrodes by pacing from the bilateral subclavian veins, and monitored during 3-minute cryoballoon applications at the ipsilateral pvs.Results one hundred ninety of 202 pvs were successfully isolated exclusively using 28-mm cryoballoons.Cmaps could be obtained in all except 3 cases with catheter inaccessibility in the left subclavian vein.The left and right cmap amplitudes were similar at baseline (1.04 ± 0.41 mv vs.1.01 ± 0.43 mv, p = 0.49).Among 105 left and 132 right pv applications while monitoring cmaps, 2 (1.9%) and 13 (9.8%) applications were interrupted for a decreased cmap amplitude (p = 0.01).Among them, cmaps decreased due to right pni in 4 applications/patients and to catheter dislodgement in the remaining applications.Pni remained in 1 and recovered in the remaining 3 patients one day after the procedure.Applications without requiring interruptions exhibited no significant cmap amplitude changes throughout the applications, and the time-course pattern was similar between the bilateral cmaps (p = 0.292).Conclusions a stable bilateral diaphragmatic cmap could be similarly obtained during cryoballoon applications in the vast majority of patients.Monitoring cmaps might be useful to anticipate not only right but also left pni during cryoballoon ablation.The literature publication reports the following complications: one (1) patient with a pneumothorax, one (1) patient with cardiac tamponade, two (2) patients with phrenic nerve injury (pni).No further patient complications were reported as a result of this event.

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.Referenced article: prospective evaluation of bilateral diaphragmatic electromyograms during cryoballoon ablation of atrial fibrillation.Journal of cardiovascular electrophysiology.2015;26(6):622-628.Concomitant medical products: 2af284 - arctic front advance cardiac cryoablation catheter.(b)(4).

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5H3; 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: 4956273
• MDR Text Key: 16959404
• Report Number: 3002648230-2015-00210
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• 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
• Treatment: 990063-020 - ACHIEVE MAPPING CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention