MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; SIMILAR DEVICE D131501, PMA # P030031/S034

Catalog Number UNK_THERMOCOOL SF NAV

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

Patient Problem Paralysis (1997)

Event Date 04/30/2016

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 female patients underwent radiofrequency ablation and suffered phrenic nerve palsy.Title: ¿poor rhythm outcome of catheter ablation for early-onset atrial fibrillation in women.¿ the purpose of this study was to investigate the effect of sex on the outcome of af catheter ablation, especially in patients with af under the age 60 years old.The 1060 consecutive patients were enrolled in this study.This study was conducted from march 2009 to april 2016.Thermocool and coolflex (st jude medical) ablation catheters were both used in this study, however it is unknown which catheter the patient used.Bwi takes conservative approach to report this event under thermocool ablation catheter.

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: SIMILAR DEVICE D131501, PMA # P030031/S034
• 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: 7742784
• MDR Text Key: 115831133
• Report Number: 2029046-2018-01883
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: KS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2018

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_THERMOCOOL SF NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2018
• Initial Date FDA Received: 08/02/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 50 YR