MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR; SIMILAR DEVICE NS7TCBL174HS, PMA # P990025

Catalog Number UNK_NAVISTAR

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

Patient Problems Laceration(s) of Esophagus (2398); Vascular Dissection (3160); No Code Available (3191)

Event Date 06/30/2005

Event Type  Injury  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because the no lot number was provided by the customer.(b)(4).

Event Description

This complaint is from a literature source.It was reported that one patient with symptomatic recurrent atrial fibrillation refractory to antiarrhythmic drugs in group b underwent radiofrequency ablation and developed a femoral artery tear requiring surgical repair, and an intramural oesophageal haematoma without evidence of atrio-oesophageal fistula at exploratory surgery, which resolved spontaneously without additional incidences.Navistar ablation catheters were used in this study, however catalog and lot number were unknown.Title: ¿cooled ablation reduces pulmonary vein isolation time: results of a prospective randomised trial.¿ the purpose of this study was to assess the efficiency of cooled ablation and standard 4 mm tip catheter ablation to achieve pv conduction block in patients with recurrent af.Thirty-six (36) patients were enrolled in this study.Study was conducted between october 2004 and june 2005.

• Brand Name: UNK_NAVISTAR
• Type of Device: SIMILAR DEVICE NS7TCBL174HS, PMA # P990025
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7440464
• MDR Text Key: 105843687
• Report Number: 2029046-2018-01440
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 04/05/2018

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 Catalogue Number: UNK_NAVISTAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2018
• Initial Date FDA Received: 04/18/2018
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 55 YR