MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) NAVISTAR? ELECTROPHYSIOLOGY CATHETER; SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

Model Number D-1183-00

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Nausea (1970); Vomiting (2144); Injury (2348); Constipation (3274)

Event Date 07/11/2011

Event Type  Injury  

Event Description

This complaint is from literature source.From the article it was reported that a (b)(6)male underwent pvi ablation.During the procedure periesophageal vagal nerve injury had occurred.The patient exhibited the following symptoms and findings after af ablation: acute onset of characteristic prolonged symptoms of gastric delayed emptying, such as nausea, vomiting, postprandial fullness, bloating, constipation, or epigastric pain.Gastroparesis was confirmed by abdominal x-ray.Metoclopramide or mosapride were orally administered after the patient was able to eat.The patient fully recovered on post-operative day 1.There is no claim of product malfunction.Title: ¿factors associated with periesophageal vagal nerve injury after pulmonary vein antrum isolation¿ the aim of this study was to identify the factors associated with the occurrence of pni in pvai, procedures using rf energy.The study was conducted between october 2010 and november 2013.From this report other 12 patients had symptomatic gastric hypomotility.These events will be reported separately.There is no death events reported in the publication.Other bwi products were used during the procedure: lasso and carto 3.

Manufacturer Narrative

(b)(4).

• Brand Name: NAVISTAR? ELECTROPHYSIOLOGY CATHETER
• Type of Device: SIMILAR DEVICE NS7TCBL174HS, PMA # P990025
• Manufacturer (Section D): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer (Section G): BIOSENSE WEBSTER, INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: jaime chavez ; 9098398483
• MDR Report Key: 4460099
• MDR Text Key: 5180979
• Report Number: 2029046-2015-00025
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/06/2015

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: Health Professional
• Device Model Number: D-1183-00
• Device Lot Number: UNKNOWN_NAVISTAR TC
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/31/2014
• Initial Date FDA Received: 01/28/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 62