MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132701

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Pulmonary Edema (2020); Pericarditis (4448)

Event Date 08/01/2022

Event Type  Injury  

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, collison farr k, ervin kr, ross js, coplan pm, drozda jp jr.Safety and effectiveness of a catheter with contact force and 6-hole irrigation for ablation of persistent atrial fibrillation in routine clinical practice.Jama netw open.2022 aug 1;5(8):e2227134.Doi: 10.1001/jamanetworkopen.2022.27134.Pmid: 35976649; pmcid: pmc9386540.Objective/methods/study data:to use health system data to compare the safety and effectiveness of the cf-i6 catheter for persistent af ablation with the thermocool smarttouch surroundflow catheter (ablation catheter with contact force and 56-hole irrigation [cf-i56]), which is approved by the fda for this indication.This retrospective, comparative-effectiveness cohort study included patients undergoing catheter ablation for persistent af at mercy health or mayo clinic from (b)(6) 2014, to (b)(6) 2021, with up to a 1-year follow-up using electronic health record data.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.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 (cf-i6) : qty 1 acute stroke (cerebrovascular accident) (recognized procedural complication).Qty 23 (pericarditis) (recognized procedural complication).Qty 3 (pulmonary edema) (recognized procedural complication).Adverse event(s) without any discussion of interventions that are possibly associated with unk_smart touch bidirectional sf (cf-i56): qty 1 acute stroke (cerebrovascular accident) (recognized procedural complication).Qty 2 (heart block) (recognized procedural complication).Qty 16 (pericarditis) (recognized procedural complication).Qty 9 (pulmonary edema) (recognized procedural complication).Qty 2 (cardiac tamponade) (recognized procedural complication).

Manufacturer Narrative

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, collison farr k, ervin kr, ross js, coplan pm, drozda jp jr.Safety and effectiveness of a catheter with contact force and 6-hole irrigation for ablation of persistent atrial fibrillation in routine clinical practice.Jama netw open.2022 aug 1;5(8):e2227134.Doi: 10.1001/jamanetworkopen.2022.27134.Pmid: 35976649; pmcid: pmc9386540.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 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 pc-001369777 has two reports: (1) mfr # 2029046-2023-01362 for product code unk_smart touch bidirectional sf.(2) mfr # 2029046-2023-01363 for product code unk_smart touch bidirectional.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 17187738
• MDR Text Key: 317733535
• Report Number: 2029046-2023-01363
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009163
• UDI-Public: 10846835009163
• 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,Company Representative
• 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 Model Number: D132701
• 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 This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening