MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_CELSIUS THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/2005

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source: hsu lf, jaïs p, hocini m, sanders p, rotter m, takahashi y, scavée c, sacher f, clémenty j, haïssaguerre m.High-density circumferential pulmonary vein mapping with a 20-pole expandable circular mapping catheter.Pacing clin electrophysiol.2005 jan;28 suppl 1:s94-8.Doi: 10.1111/j.1540-8159.2005.00061.X.Pmid: 15683537.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 not provided by the customer.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source: hsu lf, jaïs p, hocini m, sanders p, rotter m, takahashi y, scavée c, sacher f, clémenty j, haïssaguerre m.High-density circumferential pulmonary vein mapping with a 20-pole expandable circular mapping catheter.Pacing clin electrophysiol.2005 jan;28 suppl 1:s94-8.Doi: 10.1111/j.1540-8159.2005.00061.X.Pmid: 15683537.Objective/methods/study data: the authors evaluated an expandable, circular 15¿25 mm diameter, 20-pole mapping catheter for pv mapping during sustained af in 25 patients.After selective pv angiography to define the ostial position and size, the catheter was introduced into each pv and withdrawn to the most stable proximal position, with optimal wall contact ensured by progressive loop expansion.At each pv ostium, electrograms recorded at high resolution (hr) were compared with those recorded at a resolution similar to that of a standard 10-pole lasso catheter.After pvi performed during ongoing af, the presence of residual far-field potentials (ffp) under both set-ups was compared.We mapped 97 pv, including 4 pairs with common ostia.In the hr recordings, the pv potentials had greater amplitude (0.5 ± 0.1 vs 0.3 ± 0.1 mv, p = 0.001) and fragmentation, whereas left atrial ffp were minimized.After successful isolation of all pv, ffp were observed in 33% of left superior and 28% of left inferior pv on the hr recordings, compared to 66% and 61%, respectively under normal resolution.Catheter stability and optimal wall contact, in combination with hr electrograms can optimize circumferential pv mapping during af and improve the discrimination of ffp post ablation.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: 4-mm irrigated-tip ablation catheter (celsius thermocool, biosense webster).4-mm irrigated-tip ablation catheter (celsius thermocool, biosense webster) will be coded as unk-celsuis.Other biosense webster concomitant devices that were also used in this study: multipolar catheter, 15¿25 mm diameter, 20-pole circular catheter (lasso 2515, biosense webster).Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions: qty 1 cardiac tamponade requiring drainage.Follow-up will be needed due to the date of the article.

• Brand Name: CELSIUS¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 15507520
• MDR Text Key: 300868256
• Report Number: 2029046-2022-02342
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 09/29/2022

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_CELSIUS THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2022
• Initial Date FDA Received: 09/29/2022
• 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
• Treatment: MULTIPOLAR,15¿25MM DIAMETER,20-POLE CIRC CATHETER
• Patient Outcome(s): Required Intervention; Life Threatening