MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR THERMOCOOL

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

Patient Problem Heart Failure (2206)

Event Date 12/31/2017

Event Type  Injury  

Manufacturer Narrative

Product complaint # (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.Information regarding patient weight, height, medical history, race, and ethnicity was not reported.Biosense webster manufacturer's report numbers: 2029046-2020-00146 is related to the same incident.

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿depolarization and repolarization parameters on ecg predict recurrence after atrial fibrillation ablation in patients with hypertrophic cardiomyopathy¿ (pmid:31441155).2 patients with primary atrial fibrillation (af) who underwent t primary catheter af ablation s developed diastolic heart failure following the procedure and the symptoms resolved shortly after diuresis initiation.Aim of this study: to identify which af patients will most likely benefit from ablation and who are more likely to show treatment failure.Methods: all hcm patients over 18 years old who underwent primary catheter ablation for symptomatic, drug-resistant af from november 2006 to december 2017 at (b)(6) hospital were screened.Bwi devices (ablation catheter (navistar thermocool) were used in this study.No devices specific information (including catalog and lot number) were provided in the article.Concomitant devices were: carto3 mapping system.

• Brand Name: UNK_NAVISTAR THERMOCOOL
• 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: 9633083
• MDR Text Key: 189863079
• Report Number: 2029046-2020-00145
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• 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: 01/06/2020
• 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: 57 YR