MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Paralysis (1997)

Event Date 01/31/2020

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).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 lot number was provided by the customer.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Biosense webster manufacturer's report numbers: 2029046-2020-01323, 2029046-2020-01324, 2029046-2020-01325, 2029046-2020-01334, 2029046-2020-01335, 2029046-2020-01336 are related to the same incident.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent catheter ablation of atrial fibrillation and suffered phrenic nerve paralysis.Intervention was not reported.(thermocool® ablation catheter).Model and catalog number are not available, but the suspected devices are: thermocool® ablation catheter.Other biosense webster devices that were also used in this study: biosense webster soundstar catheter, carto lasso, carto pentaray , carto 3 non-biosense webster devices that were also used in this study: boston scientific intellamap orion¿, boston scientific intella nav¿ open-irrigated ablation catheter, boston scientific intella tip mifi¿ open irrigated ablation catheter, boston scientific rhytmia® hdm.Publication details: title: advantages of the integration of ice and 3d electroanatomical mapping and ultrasound-guided femoral venipuncture in catheter ablation of atrial fibrillation.Objective: to evaluate how the integration of intracardiac echocardiography (ice) and ultrasound-guided femoral venipuncture (usgvc) may affect the safety of catheter ablation (ca) of atrial fibrillation (af).Methods: from a single center 374 patients with af underwent 3d electroanatomic mapping¿guided ca with or without the integration of ice and usgvc.The primary endpoints were periprocedural complications, fluoroscopy time, and procedure time between the two groups.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• Type of Device: UNK
• 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: 10597664
• MDR Text Key: 209011749
• Report Number: 2029046-2020-01337
• Device Sequence Number: 1
• Product Code: LPB
• 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: Physician
• Type of Report: Initial
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2020
• 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: 60 YR