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 Stroke/CVA (1770); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440)

Event Date 01/01/2022

Event Type  Injury  

Event Description

This complaint is from a literature source.Yang zexin, shi liang, wang yanjiang, etc.Active coagulation time in atrial fibrillation rf ablation is maintained at a safe mouth of 220~270 s.].Journal of clinical cardiovascular disease, 2022, 38(6):467-471.Dor:10.13201/j.Isn.1001-14 39.2022 06.008.Objective/methods/study data: the aim of the present study was to assess the safety of maintaining active coagulation time (act) slightly below the recommended limits in guidelines during catheter ablation in patients with atrial fibrillation (atrial fibrillation).This study is a single-center retrospective study.The study has continuously selected 1065 patients who performed atrial fibrillation rf ablation at beijing chaoyang hospital, affiliated with capital medical university, by january 1- june 2021 in 2017.In 1065 patients continuously included in atrial fibrillation rf ablation, 100 u/kg of heparin was given by weight after a successful single atrial sepsis.After that, every 15 to 20 min, measure act, add 1000-2000 u heparin per measurement according to the act, and the act target range is 220 to 270 s.Pulmonary venous isolation and left atrial ablation are performed with cold saline perfusion ablation catheters.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: smart touch st cold saline perfusion ablation catheter, ) coded as unk_smart touch bidirectional.Other biosense webster devices that were also used in this study: carto 3, pentaray multielectrode catheter, non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions.Qty 1 cerebral embolism coded as cerebrovascular accident - anticoagulant treatments improved symptoms after 3 days.Qty 1 great saphenous vein thrombosis coded as deep vein thrombosis-improved after anticoagulation.Qty 10 acute cardiac pressure coded as cardiac tamponade-9 cases followed pericardial piercing drainage treatment and the bleeding stopped to improve; 1 case was released after emergency thoracic surgery and open thoracic surgery.

Manufacturer Narrative

This complaint is from a literature source.Yang zexin, shi liang, wang yanjiang, etc.Active coagulation time in atrial fibrillation rf ablation is maintained at a safe mouth of 220~270 s.].Journal of clinical cardiovascular disease, 2022, 38(6):467-471.Dor:10.13201/j.Isn.1001-14 39.2022 06.008.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 no lot number was 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.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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15602410
• MDR Text Key: 301730871
• Report Number: 2029046-2022-02518
• 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
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2022
• 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: 09/21/2022
• 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: CARTO 3; PENTARAY MULTIELECTRODE CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention