MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_THERMOCOOL SF NAV; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NAV

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

Patient Problem Paralysis (1997)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).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 no lot number was provided by the customer.Biosense webster manufacturer's report numbers: 2029046-2020-00422.2029046-2020-00423.Are related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿clinical factors associated with a successful catheter ablation outcome in elderly patients with atrial fibrillation¿.4 patients with symptomatic paroxysmal atrial fibrillation (af) who underwent af ablation procedure experienced transient phrenic nerve injury during the svc isolation, which recovered within a month.

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9836902
• MDR Text Key: 191691286
• Report Number: 2029046-2020-00422
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2020
• 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
• Date Manufacturer Received: 02/24/2020
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 77 YR