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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Pulmonary Edema (2020); Perforation of Vessels (2135); Cardiac Tamponade (2226); Thrombosis/Thrombus (4440); Heart Block (4444); Pericarditis (4448)

Event Date 01/01/2021

Event Type  Injury  

Event Description

This complaint is from a database related research activities.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.Adverse event(s) reported for thermocool smarttouch catheter for cardiac ablation procedure: qty 1 acute stroke/cerebrovascular accident within 7 days of the index ablation.Qty 23 pericarditis within 7 days of the index ablation.Qty 3 pulmonary edema within 7 days of the index ablation.Qty 2 major vascular access complication or bleeding requiring transfusion within 7 days of the index ablation.Qty 1 vascular injury within 7 days of the index ablation.Adverse event(s) reported for thermocool smarttouch sf catheter for cardiac ablation procedure: qty 1 acute stroke/cerebrovascular accident within 7 days of the index ablation.Qty 2 heart block within 7 days of the index ablation.Qty 16 pericarditis within 7 days of the index ablation.Qty 9 pulmonary edema within 7 days of the index ablation.Qty 4 major vascular access complication or bleeding requiring transfusion within 7 days of the index ablation.Qty 2 cardiac tamponade/performation 30 days of the index ablation.Qty 1 deep venous thrombosis 7 days of the index ablation.Qty 1 pericardial effusion with hemodynamic compromise within 7 days of the index ablation.Qty 1 vascular injury within 7 days of the index ablation.

Manufacturer Narrative

This report is one of three medwatch reports submitted based on the study findings.The other two reports are manufacturer report number: (b)(4).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13256589
• MDR Text Key: 287428708
• Report Number: 2029046-2022-00086
• Device Sequence Number: 1
• Product Code: LPB
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2022
• 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
• Date Manufacturer Received: 12/20/2021
• 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): Required Intervention; Life Threatening