MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: ding x, wang l, liu q, chen s, jiang r, yu l, zhang p, lin j, sun y, sheng x, fu g, zei pc, jiang c.Use of intracardiac echocardiography in vein of marshall ethanol infusion for ablation of persistent atrial fibrillation.Heart rhythm.2024 mar;21(3):274-281.Doi: 10.1016/j.Hrthm.2023.11.029.Epub 2023 dec 14.Pmid: 38103707.Objective/methods/study data: background: few methods have been reported to demonstrate real-time effects during vein of marshall (vom) ethanol infusion in persistent atrial fibrillation (peaf).Objective: this study was to evaluate the impact of left atrial (la) monitoring using intracardiac echocardiography (ice) during vom ethanol infusion.Methods: seventy-four consecutive patients with peaf who underwent vom ethanol infusion followed by radiofrequency (rf) ablation were included.Patients with findings on ice consistent with echogenic streaming in the la and with increased myocardial local echogenicity along the vom area were placed into one group (group a) and those without into the other group (group b).Outcomes between the 2 groups were compared.Results: forty-six patients (62%) were placed into group a.A new ethanol-induced low-voltage area in group a was larger than that in group b (8.5 cm2 [5.5-10.2 cm2] and 4.0 cm2 (2.4-6.3 cm2]; p <.001).The rf ablation time required to achieve mi block was reduced in group a patients (263.0 seconds [196.0-351.0 seconds] vs 417.0 seconds [315.0-709.5 seconds] in group b patients; p <.001).Mi block was achieved in 46 patients (100%) via an endocardial approach in group a and 27 patients (96.4%) in group b (extra coronary sinus ablation in 4 patients).One patient developed clinically significant pericardial effusions and required pericardiocentesis in group b.Conclusion: presence of increased myocardial local echogenicity at the ridge and consistent echogenic streaming in the la detected by ice-based imaging during vom ethanol infusion suggests increased ablated tissue in that region and lower rf ablation time during ablation for peaf.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch ablation catheter and 7-f decanav cs catheter concomitant biosense webster devices that were used in this study: pentaray mapping catheter, carto3 mapping system, 7-f decanav cs catheter concomitant non-biosense webster devices that were also used in this study: runthrough ns extra floppy guidewire (terumo), otw balloon (boston scientific), ht viewer mapping system (apt medical) adverse event(s) and provided interventions possibly associated with unidentified thermocool smarttouch ablation catheter: qty 5 (pericardial effusion)(recognized procedural complication) qty 1 pericardial effusions and required pericardiocentesis (cardiac tamponade)(recognized procedural complication) adverse event(s) and provided interventions possibly associated with unidentified 7-f decanav cs catheter: qty 3 cs dissection during cs venography (vascular dissection)(recognized procedural complication).

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: ding x, wang l, liu q, chen s, jiang r, yu l, zhang p, lin j, sun y, sheng x, fu g, zei pc, jiang c.Use of intracardiac echocardiography in vein of marshall ethanol infusion for ablation of persistent atrial fibrillation.Heart rhythm.2024 mar;21(3):274-281.Doi: 10.1016/j.Hrthm.2023.11.029.Epub 2023 dec 14.Pmid: 38103707.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 803.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.Biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00870 for a thermocool® smart touch¿ bi-directional navigation catheter (2) mfr # 2029046-2024-00871 for a decanav electrophysiology catheter.

Manufacturer Narrative

On 27-mar-2024, additional information was received from the author of the article indicating there was no relevance between the harm and the bwi product in the article.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18923198
• MDR Text Key: 337896528
• Report Number: 2029046-2024-00870
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/27/2024
• 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: 7-F DECANAV CS CATHETER; 7FR DECAN,11P,F,2.4MMLE,282MM,; CARTO3 MAPPING SYSTEM; HT VIEWER MAPPING SYSTEM (APT MEDICAL); OTW BALLOON (BOSTON SCIENTIFIC); PENTARAY MAPPING CATHETER; RUNTHROUGH NS EXTRA FLOPPY GUIDEWIRE (TERUMO)
• Patient Outcome(s): Life Threatening