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

Catalog Number UNK_THERMOCOOL SF NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericarditis (4448)

Event Date 09/07/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: fukasawa k, umetani k, yano t, sano k.Constrictive pericarditis following atrial fibrillation catheter ablation with cardiac tamponade.Heartrhythm case rep.2021 sep 17;7(12):836-839.Doi: 10.1016/j.Hrcr.2021.09.007.Pmid: 34987971; pmcid: pmc8695298.Objective/methods/study data: radiofrequency catheter ablation (ca) has become an increasingly common procedure to treat atrial fibrillation (af) because of the efficacy and safety.In a recent trial, the complication rate has gradually decreased, but cardiac tamponade is still a serious complication, occurring in 0.8%¿1.0% of 1¿3 patients.Even with a lower rate of procedure-related complications, operators should be familiar with the complications and how to treat them.In the midterm evaluation of patients with ca-related cardiac tamponade, acute pericarditis ,2,4 occurred in 34%¿53% of the patients, but during the follow-up period constrictive pericarditis was not reported.Only 2 case reports described ca-related constrictive pericarditis.They present a case of constrictive pericarditis following ca to treat af and cardiac tamponade.This is the first case report associated with cardiac tamponade.Ca-related constrictive pericarditis is a very rare complication; however, to treat ca-related constrictive pericarditis appropriately, clinical information must be available.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch.Other biosense webster concomitant devices that were also used in this study: carto3 version 6.Non-biosense webster concomitant devices that were also used in this study: n/a adverse event(s) and provided interventions: the patient experienced; cardiac tamponade requiring pericardiocentesis and constrictive pericarditis.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: fukasawa k, umetani k, yano t, sano k.Constrictive pericarditis following atrial fibrillation catheter ablation with cardiac tamponade.Heartrhythm case rep.2021 sep 17;7(12):836-839.Doi: 10.1016/j.Hrcr.2021.09.007.Pmid: 34987971; pmcid: pmc8695298.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.Manufacturer¿s reference number: (b)(4).

• Brand Name: UNK_THERMOCOOL SF NAV
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14639317
• MDR Text Key: 293851511
• Report Number: 2029046-2022-01233
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2022

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
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO3 VERSION 6; THERMOCOOL SMARTTOUCH
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 69 YR
• Patient Sex: Male