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 Problem Unspecified Tissue Injury (4559)

Event Date 02/04/2023

Event Type  Injury  

Manufacturer Narrative

Manufacture ref no.: (b)(4).This complaint is from a literature source.The following literature cite has been reviewed: dhruva ss, zhang s, chen j, noseworthy pa, doshi aa, agboola km, herrin j, jiang g, yu y, cafri g, farr kc, mbwana ms, ross js, coplan pm, drozda jp jr.Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia.J interv card electrophysiol.(b)(6) 2023.Doi: 10.1007/s10840-023-01496-x.Epub ahead of print.Pmid: 36738387.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 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.

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: dhruva ss, zhang s, chen j, noseworthy pa, doshi aa, agboola km, herrin j, jiang g, yu y, cafri g, farr kc, mbwana ms, ross js, coplan pm, drozda jp jr.Using real-world data from health systems to evaluate the safety and effectiveness of a catheter to treat ischemic ventricular tachycardia.J interv card electrophysiol.(b)(6) 2023.Doi: 10.1007/s10840-023-01496-x.Epub ahead of print.Pmid: 36738387.Objective/methods/study data:methods among patients undergoing ischemic vt ablation with the thermocool stsf catheter pooled across two health systems (mercy health and mayo clinic), the primary safety composite outcome of death, thromboembolic events, and procedural complications within 7 days was compared to a performance goal of 15%, which is twice the expected proportion of the primary composite safety outcome based on prior studies.The exploratory effectiveness outcome of rehospitalization for vt or heart failure or repeat vt ablation at up to 1 year was averaged across health systems among patients treated with the thermocool stsf vs.St catheters.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smartouch ablation catheter and thermocool smartouch sf ablation catheter.Other biosense webster devices that were also used in this study: n/a.Non-biosense webster devices that were also used in this study: n/a.Exact quantities of products cannot be accurately determined as patients can experience more than adverse event and the data is summarized.Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional sf: qty 1 deep venous thrombosis (deep vein thrombosis)(considered serious injury).Qty 1 pericardial effusion with hemodynamic compromise (cardiac tamponade).(recognized procedural complication).Qty 1 vascular injury (soft tissue injury) (considered serious injury).Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional: qty 1 vascular injury (soft tissue injury) (considered serious injury).

• 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: 17186862
• MDR Text Key: 317727859
• Report Number: 2029046-2023-01356
• 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: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2023
• 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: 05/25/2023
• 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
• Patient Outcome(s): Life Threatening