MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SF BI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_THERMOCOOL SF NON NAV

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hematoma (1884); Transient Ischemic Attack (2109)

Event Date 11/27/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: yazaki k, ejima k, kataoka s, higuchi s, kanai m, yagishita d, shoda m, hagiwara n.Prognostic significance of post-procedural left ventricular ejection fraction following atrial fibrillation ablation in patients with systolic dysfunction.Circ rep.2020 nov 27;2(12):707-714.Doi: 10.1253/circrep.Cr-20-0111.Pmid: 33693200; pmcid: pmc7937527.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 no lot number was provided by the customer.The literature file is too large and therefore, unable to attach.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: yazaki k, ejima k, kataoka s, higuchi s, kanai m, yagishita d, shoda m, hagiwara n.Prognostic significance of post-procedural left ventricular ejection fraction following atrial fibrillation ablation in patients with systolic dysfunction.Circ rep.2020 nov 27;2(12):707-714.Doi: 10.1253/circrep.Cr-20-0111.Pmid: 33693200; pmcid: pmc7937527.Objective/methods/study data: this retrospective observational study screened 1,077 consecutive patients undergoing radiofrequency catheter ablation for atrial fibrillation.Of the 1,077 consecutive patients undergoing atrial fibrillation ablation, the prognosis of 150 patients with abnormal left ventricular ejection fraction was evaluated.Patients were categorized as having reduced left ventricular ejection fraction, mid-range ejection fraction, or preserved left ventricular ejection fraction.This study explored the association between post-procedural left ventricular ejection fraction at 3 months and prognosis in patients who underwent atrial fibrillation ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool, thermocool sf or thermocool smarttouch sf.Concomitant biosense webster device (s) that were also used in this study: carto 3 non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: procedure-related complications were observed in 2 patients.1 patient experienced transient ischemic attack immediately after the procedure, no treatment specified.1 patient had intra-abdominal hematoma due to wire perforation, no treatment specified, which recovered without blood transfusion.

• Brand Name: THERMOCOOL® SF BI-DIRECTIONAL CATHETER
• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13497645
• MDR Text Key: 285625703
• Report Number: 2029046-2022-00254
• 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,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2022

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 NON NAV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/13/2022
• Initial Date FDA Received: 02/09/2022
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other