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

Catalog Number UNK_CELSIUS THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 05/16/2021

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).Investigation summary: since the product has not been returned, no corrective action is warranted at this time.As a result, we are closing this investigation.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: mori h, kawano d, sumitomo n, muraji s, nabeshima t, tsutsui k, ikeda y, iwanaga s, nakano s, muramatsu t, kobayashi t, kato r, matsumoto k.Ultrahigh density atrio-ventricular dual-chamber mapping as a next generation tool for ablation of accessory pathways.J cardiovasc electrophysiol.2021 jul;32(7):1877-1883.Doi: 10.1111/jce.15070.Epub 2021 may 16.Pmid: 33955099.Objective: detailed three-dimensional (3d) mapping has been useful for effective radiofrequency catheter ablation.The rhythmia system can create atrio-ventricular dual-chamber mapping, which reveals the atrial and ventricular potentials all at once in the same map.The aim of this study was to investigate the utility of mapping the atrium and ventricle simultaneously with a high-density 3d mapping system for the ablation of accessory pathways (ap).Methods/study data: from july 2015 to august 2020, 111 patients underwent ablation of aps.Dual-chamber maps were created in 50 patients (median age 15 [10-54], 32 male [64.0%]), while 61 patients underwent radiofrequency (rf) ablation with conventional single-chamber 3d maps.The background characteristics and procedural details were compared between the dual-chamber mapping group and the conventional single-chamber mapping group.The mapping and ablation were performed under the guidance of a carto system (bwi), ensite system (abbott medical), or rhythmia system (boston scientific).All ablation procedures were performed using a non-irrigation catheter (navistar, bwi or blazer, boston scientific) or irrigation catheter (celsius, bwi or intella nav oi mifi, boston scientific) at the operator's discretion and the delivered rf power was set at 30¿40 w.When the catheter contact was insufficient at the site of the ap based on the local bipolar potential, a contact force catheter was used (smart touch stsf, bwi) the ablation energy was usually delivered at the earliest atrial activation site on the av groove under burst ventricular pacing.Successful ablation was defined as a conduction interruption of the aps.Acute success was obtained in all patients.Cardiac tamponade requiring pericardiocentesis was observed in one patient during the rv catheter insertion.The authors concluded that the dual-chamber mapping was useful for achieving an effective ablation while reducing radiation exposure.Mapping the atrium and ventricle all at once was useful for understanding the detailed connections of aps.Shorter radiation exposure would be useful for patients and the medical staff.Of note: the authors used ablation catheters from 2 different manufacturers, chosen at random, but did not provide information to associate the adverse events with specific device manufacturers.The actual number of bwi devices associated with the cardiac tamponade is unknown.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar non-irrigated ablation catheter.Celcius irrigated ablation catheter.Other biosense webster devices that were also used in this study: carto 3d mapping system.Non-biosense webster devices that were also used in this study: ensite system (abbott medical), or rhythmia system (boston scientific)- 3d mapping.Blazer ii non irrigated ablation catheter, boston scientific.Intella nav oi mifi, irrigated ablation catheter, boston scientific.Adverse event(s) and provided interventions: please note: the authors do not specify which product is related to the periprocedureal complications: cardiac tamponade requiring pericardiocentesis was observed in one patient during the rv catheter insertion.".

• Brand Name: UNK_CELSIUS THERMOCOOL
• Type of Device: CARDIAC ABLATION 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 drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 12396752
• MDR Text Key: 273560063
• Report Number: 2029046-2021-01463
• Device Sequence Number: 1
• Product Code: OAD
• 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,health professional,l
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/03/2021

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: No Information
• Device Catalogue Number: UNK_CELSIUS THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2021
• Initial Date FDA Received: 08/31/2021
• 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
• Patient Outcome(s): Required Intervention