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 Transient Ischemic Attack (2109); Cardiac Tamponade (2226); Vascular Dissection (3160); Heart Block (4444)

Event Date 03/25/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: rexha e, heeger ch, maack s, rottner l, wohlmuth p, lemes c, maurer t, reissmann b, rillig a, mathew s, sohns c, ouyang f, kuck kh, metzner a.Impact of a time-to-effect-guided ablation protocol in cryoballoon ablation on the durability of pulmonary vein isolation.J cardiovasc electrophysiol.2022 jun;33(6):1096-1103.Doi: 10.1111/jce.15453.Epub 2022 mar 25.Pmid: (b)(6).Objective/methods/study data: background: cryoballoon (cb)-based pulmonary vein isolation (pvi) has proven to be as effective as radiofrequency-based ablation.Different ablation protocols took the individual time-to-isolation (tti) into account aiming at shorter but equally or even more effective freeze cycles.The current study sought to assess the impact of the tti on pvi durability in patients undergoing a repeat procedure for recurrence of atrial tachyarrhythmia (ata).Methods and results: in 205 patients with ata recurrence after previous cb-based pvi, a total of 806 pulmonary veins (pvs) were identified.A total of 126 out of 806 pvs (16%) were previously treated with a tti-guided ablation (protocol #1; tti + 120 s), in 92/806 (11%) pvs tti was only monitored (m) but fixed freeze cycles were applied (protocol #2; mtti) and in 588/806 (73%) a fixed freeze cycle was applied without mtti.There was no difference in the pv-reconduction rate between the groups (p =.23).The right inferior pulmonary vein (ripv) showed overall significantly higher reconduction rates compared to the other pvs (ripv¿left inferior pv p <.003, ¿left superior pv p <.001, ¿right superior pv p <.013).Twenty-one patients (10%) were demonstrated to have only electrical reconduction of the ripv, while all other pvs were still electrically isolated.-conclusions: the tti-based cb ablation protocol did not show significant differences regarding pv-reconduction rates compared to the other ablation protocols.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: -thermocool®; biosense webster inc.Other biosense webster concomitant devices that were also used in this study: -carto; biosense webster inc.-lassotm; biosensewebster non-biosense webster devices that were also used in this study: -achieve catheter; medtronic inc.Adverse event(s) and provided interventions: complications were documented in 8 patients that could be associated with bwi devices: 4 pericardial tamponade which occurred in pericardiocentesis was performed in all four patients no surgery was required.1 patient had a transient ischemic attack.1 transient sinus arrest (heart block).1 transient av-block iii° (heart block av ).1 dissection of the coronary sinus (vascular dissection).No additional information was provided regarding intervention or outcomes.

Manufacturer Narrative

Manufacturer's ref no: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: rexha e, heeger ch, maack s, rottner l, wohlmuth p, lemes c, maurer t, reissmann b, rillig a, mathew s, sohns c, ouyang f, kuck kh, metzner a.Impact of a time-to-effect-guided ablation protocol in cryoballoon ablation on the durability of pulmonary vein isolation.J cardiovasc electrophysiol.2022 jun;33(6):1096-1103.Doi: 10.1111/jce.15453.Epub 2022 mar 25.Pmid: (b)(6).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.

• 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: 15325631
• MDR Text Key: 298950315
• Report Number: 2029046-2022-02049
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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
• Report Date: 08/30/2022

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_SMART TOUCH BIDIRECTIONAL
• 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 EPI ABBOTT, ST PAUL; CARTO-3 SYSTEM; ENSITE VELOCITY NAVIGATION SYSTEM; LONG SHEATH (AGILIS-L ABBOTT, ST PAUL, MN, US); THERAPY¿ COOL FLEX¿ ABLATION CATHETER, ABBOTT,
• Patient Outcome(s): Required Intervention; Life Threatening