MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC (IRWINDALE) CELSIUS DS; SIMILAR DEVICE D7TCD8L162RT, PMA # P010068

Model Number CELSIUS DS

Device Problem Insufficient Information (3190)

Patient Problem Thrombosis (2100)

Event Date 05/01/2006

Event Type  Injury  

Event Description

Event description: this complaint is from literature source.From the article: - 1 patient had experienced pulmonary vein stenosis.Multiple attempts were done to request for further details of the event.However no additional information has been provided.Title: impact of systematic isolation of superior vena cava in addition to pulmonary vein antrum isolation on the outcome of paroxysmal, persistent, and permanent atrial fibrillation ablation: results from a randomized study objectives: the purpose of the study was to investigate the impact resulting from the systematic isolation of the superior vena cava (svci) in addition to pulmonary vein antrum isolation (pvai) on the outcome of paroxysmal, persistent, and permanent af ablation.A total of 320 consecutive patients who had been referred to the center in order to undergo a first attempt of af ablation were randomized into 2 groups.Group i (160 patients) underwent pvai only; group ii (160 patients) underwent pvai and svci.Data collected from 320 consecutive patients who had been referred to the center for catheter ablation of symptomatic af refractory to at least 1 antiarrhythmic drug (aad) between january 2004 and may 2006.Other adverse events were reported in this article: in the pvi group: - 1 patient had experienced deep-vein thrombosis.- 1 patient had experienced cerebrovascular accident, - 1 patient had experienced cardiac tamponade, in the pvi + svci group, -1 patient had experienced coronary artery embolism.There are no death events and device malfunctions reported in the publication.Model and catalog number are not available, but the suspected device is the an 8-mm radiofrequency ablation catheter celsius ds.Other bwi products reported in the article: circular mapping catheter lasso.Other devices: acunav, (b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: CELSIUS DS
• Type of Device: SIMILAR DEVICE D7TCD8L162RT, PMA # P010068
• 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: shahe garabedian ; 9098397362
• MDR Report Key: 4769313
• MDR Text Key: 5791534
• Report Number: 2029046-2015-00135
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 04/16/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CELSIUS DS
• Device Lot Number: UNKNOWN_CELSIUS DS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR