MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number SEE H10

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Arrhythmia (1721); Laceration(s) of Esophagus (2398); Pericardial Effusion (3271); Thrombosis/Thrombus (4440); Pericarditis (4448)

Event Date 05/06/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature citation has been reviewed: müller j, nentwich k, berkovitz a, ene e, sonne k, chakarov i, barth s, waechter c, lüsebrink u, behnes m, akin i, deneke t.Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.J cardiovasc electrophysiol.2022 jul;33(7):1425-1434.Doi: 10.1111/jce.15504.Epub 2022 may 6.Pmid: 35441414.Objective/methods/study data: the aim of the study was to investigate the efficacy and safety of hpsd (high power short duration) ablation in patients over 75 years compared to younger patients.A total of 540 patients underwent a first af ablation with hpsd (66 ± 10 years; 58% male; 47% paroxysmal af).Mean age was 78 ± 2.4 and 63 ± 6.3 years (p <.001), respectively.Elderly patients were significantly more often women (p <.001).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch sf catheter.Other biosense webster devices that were also used in this study: carto 3 mapping system, lasso mapping catheter, smartablate generate non-biosense webster devices that were also used in this study: agilis 8.5-french sheath (abbot).Adverse event(s) and provided interventions: qty 1 demasking of sick sinus syndrome with concomitant pacemaker implantation was significantly increased.Qty 1 patient showed symptoms of pericarditis, which were successfully treated with colchicum.Qty 1 thromboembolic complications - noted as a major complication.Qty 14 pericardial effusion - noted to be minor complication.Qty 43 thermal esophagus lesion that were endoscopically detected- noted to be minor complication.

Manufacturer Narrative

Manufacturer's ref no: (b)(4).This complaint is from a literature source.The following literature citation has been reviewed: müller j, nentwich k, berkovitz a, ene e, sonne k, chakarov i, barth s, waechter c, lüsebrink u, behnes m, akin i, deneke t.Efficacy and safety of high-power short duration atrial fibrillation ablation in elderly patients.J cardiovasc electrophysiol.2022 jul;33(7):1425-1434.Doi: 10.1111/jce.15504.Epub 2022 may 6.Pmid: 35441414.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no 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.Catalog should be "unk_smart touch unidirectional sf".

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15328008
• MDR Text Key: 298980963
• Report Number: 2029046-2022-02054
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 08/31/2022

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: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/31/2022
• 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: AGILIS 8.5-FRENCH SHEATH (ABBOT); CARTO 3 MAPPING SYSTEM; LASSO MAPPING CATHETER; SMARTABLATE GENERATE
• Patient Outcome(s): Life Threatening; Required Intervention