MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH; CATHETER, INTRODUCER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Pulmonary Valve Stenosis (2024)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the causes of the reported phrenic nerve palsy and pulmonary vein stenosis could not be conclusively determined.

Event Description

The following article titled, "usefulness of the steerable sheath for atrial fibrillation ablation" was presented on at the (b)(6)."one hundred four patients with af (84 cases paroxysmal, 20 cases persistent af) underwent left atrial abl from march 2015 to december 2016.The ablation catheter was handled with the steerable sheath (agillis nxt, st jude medical) and circumferential mapping catheter was placed with fixed curve sheath.Mapping and abl were performed under guidance of 3d mapping system.There was a tendency of correlation between the study number and total procedure time, pv isolation time, total fluoroscopic exposure does, and mapping time (p=0.0028).There were no complications such as cardiac tamponade or stroke.1 patient had phrenic nerve palsy and 2 patients had severe pulmonary vein stenosis.Af free rate at chronic phase (8.6±5.1 month after ablation) was 84.7%.Pv isolation time was reduced with steerable sheath catheter navigation technique, mapping time or additional ablation time were also reduced by the ablation number.So one of the reason of reducing total procedure time was getting skilled operators and staff of the laboratory.".

• Brand Name: AGILIS¿ NXT STEERABLE INTRODUCER DUAL-REACH¿ 61 CM SHEATH, SMALL CURL DUAL-REACH
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7053991
• MDR Text Key: 92793987
• Report Number: 2182269-2017-00143
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other