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

Catalog Number SEE SECTION 10

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pulmonary Edema (2020); Heart Block (4444)

Event Date 06/01/2017

Event Type  Death  

Manufacturer Narrative

B2.Date of death - the exact date of death is unknown at this time and so this field was populated with 28-sep-2023 which is the date of the drra report submission.Section d4: the catalog for this is unk_smart touch bidirectional sf.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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 (b)(4) has five reports: (1) mdr # for id (b)(6) experienced complete heart block (heart block av) and (pulmonary edema) within 7 days of index ablation procedure.This patient also died within 88 days of the safety evaluation period but the cause of death information is not available.(2) mfr # 2029046-2023-02441 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(3) mfr # 2029046-2023-02442 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(4) mfr # 2029046-2023-02443 for id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.(5) mfr # 2029046-2023-02444 for id (b)(6) experienced atrio-ventricular block, second degree (heart block) and acute pulmonary edema (pulmonary edema) within 7 days of index ablation procedure.

Event Description

A database related research activity (drra) was received regarding the study: ''real-world experience of persistent atrial fibrillation catheter.Ablation with thermocool smarttouch sf catheter.36-month interim report (pas progress report)''.Table 8 of report lists adverse events per patient that occurred within safety evaluation period.Adverse events and interventions possibly associated with use of an unidentified thermocool smarttouch® sf catheters: qty 1 - id (b)(6) experienced atrio-ventricular block, second degree (heart block) and acute pulmonary edema (pulmonary edema) within 7 days of index ablation procedure.Qty 1 - id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.Qty 1 - id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.Qty 1 - id (b)(6) experienced cardiac tamponade/perforation (cardiac tamponade) requiring pericardiocentesis (recognized procedural complication) within 30 days of index ablation procedure.Qty 1 - id (b)(6) experienced complete heart block (heart block av) and (pulmonary edema) within 7 days of index ablation procedure.This patient also died within 88 days of the safety evaluation period but the cause of death information is not available.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 18013238
• MDR Text Key: 326632881
• Report Number: 2029046-2023-02440
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: SEE SECTION 10
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/28/2023
• 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): Death; Life Threatening