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

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Hemorrhage/Bleeding (1888); Paralysis (1997); Pulmonary Edema (2020); Transient Ischemic Attack (2109); Pericarditis (4448)

Event Date 01/01/2021

Event Type  Injury  

Manufacturer Narrative

Unk_smart touch bidirectional (7 day post index) events reported under (b)(4) under mrn 2029046-2022-00083.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturer record evaluation cannot be conducted because the 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that this complaint is from a database related research activities (reg20_01 nestcc test case 07 phase 2 study).Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool smarttouch catheter and thermocool smarttouch sf catheter.Exact quantities of products cannot be accurately determined as a patient can experience more than one sign/symptom/health impact.Additional information received on 14-apr-2023 for results of 90 days from index ablation.Accurate number of products cannot be determined as a patient can experience more than one adverse event.The following accounts for any new adverse events that were not previously reported at 7 and 30 days of the index ablation: adverse event(s) reported for thermocool smarttouch catheter for cardiac ablation procedure for 90 days of index procedure not previously captured: qty 1 transient ischemic attack within 90 days of the index ablation; qty 2 pericarditis within 90 days of the index ablation; qty 1 diaphragmatic paralysis within 90 days of the index ablation; qty 17 pulmonary edema within 90 days of the index ablation; qty 1 major vascular access complication or bleeding requiring transfusion within 90 days of the index ablation.Adverse event(s) reported for thermocool smarttouch sf catheter for cardiac ablation procedure for 90 days of index procedure not previously captured: qty 1 death within 90 days of the index ablation; qty 1 acute myocardial infarction within 90 days of the index ablation; qty 3 acute stroke/cerebrovascular accident within 90 days of the index ablation; qty 1 transient ischemic attack within 90 days of the index ablation; qty 1 thromboembolism within 90 days of the index ablation; qty 2 pericarditis within 90 days of the index ablation; qty 1 diaphragmatic paralysis within 90 days of the index ablation; qty 22 pulmonary edema within 90 days of the index ablation; qty 2 cardiac tamponade/perforation 90 days of the index ablation; qty 1 atrioesophageal fistula within 90 days of the index ablation.

• 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: 16889379
• MDR Text Key: 314770794
• Report Number: 2029046-2023-00976
• 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: Study,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2023
• 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
• Date Manufacturer Received: 04/14/2023
• 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