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

Catalog Number UNK_SMARTTCH BIDIRECT

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 11/25/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: akhtar t, wallace r, daimee ua, sivasambu b, hart e, yang e, marine je, berger r, calkins h, spragg d.Safety and efficacy of cryoballoon versus radiofrequency ablation for atrial fibrillation in elderly patients: a real-world evidence.Indian pacing electrophysiol j.2022 jan-feb;22(1):24-29.Doi: 10.1016/j.Ipej.2021.11.006.Epub 2021 nov 25.Pmid: 34838748; pmcid: pmc8811282.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.Manufacturer's reference number: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: akhtar t, wallace r, daimee ua, sivasambu b, hart e, yang e, marine je, berger r, calkins h, spragg d.Safety and efficacy of cryoballoon versus radiofrequency ablation for atrial fibrillation in elderly patients: a real-world evidence.Indian pacing electrophysiol j.2022 jan-feb;22(1):24-29.Doi: 10.1016/j.Ipej.2021.11.006.Epub 2021 nov 25.Pmid: 34838748; pmcid: pmc8811282.Objective/methods/study data: background: there are limited data describing the experience of radiofrequency (rf) vs.Cryoballoon (cb) ablation for atrial fibrillation (af) among elderly patients in the united states.Methods: we conducted a retrospective analysis of patients 75 years of age undergoing index rf vs.Cb ablation between january 2014 and may 2020 at our center.The choice of ablation technique was left to the operator's discretion.Major complications and efficacy, defined as freedom from any atrial tachyarrhythmia (ata) lasting 30 s after one year of follow-up, were assessed in patients with index rf vs.Cb ablation.Results: in our cohort of 186 patients, the median age was 78 (76e81) years, 54.8% were men, and 39.2% had persistent af.The median cha2ds2-vasc score was 4 (3e4), while the median duration of af was 3 (1e7) years.The majority (n ¼ 112, 60.2%) underwent rf ablation.The median procedure time was significantly lower in cb group (197 vs 226.5 min, p¼<0.01).The incidence of complications was similar in the two sub-groups (rf: 1.8% vs.Cb: 2.7%, p ¼ 0.67).Similarly, arrhythmia-free survival rate on antiarrhythmic drugs at 1-year follow-up remained statistically comparable (63.4% vs.68.9%, p ¼ 0.33) between patients receiving rf vs.Cb ablation.Conclusion: the safety and efficacy of rf vs.Cb ablation for af remained comparable in our cohort of patients older than 75 years.Cb ablation was associated with a shorter procedure time.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch, biosense-webster: other biosense webster concomitant devices that were also used in this study: lasso, pentaray mapping catheter (biosense-webster, diamond bar, california), carto system.Non-biosense webster concomitant devices that were also used in this study: arctic front advance, medtronic.Adverse event(s) and provided interventions: 1 patient suffered cardiac tamponade.1 patient suffered pericardial effusion.Both patients required prolonged hospitalization.There was no mention of medical interventions provided.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14728833
• MDR Text Key: 294281202
• Report Number: 2029046-2022-01361
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2022

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_SMARTTCH BIDIRECT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/20/2022
• Initial Date FDA Received: 06/17/2022
• 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: ARCTIC FRONT ADVANCE, MEDTRONIC; CARTO SYSTEM; LASSO; PENTARAY MAPPING CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization