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

Model Number D134805

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

Patient Problem Cardiac Tamponade (2226)

Event Date 11/11/2019

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturing record evaluation (mre) review cannot be conducted because no lot number was provided by the customer.Manufacturer's reference # (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.During the procedure, a pericardial effusion was noticed as the patient's blood pressure dropped.The pericardial effusion was discovered and confirmed by intracardiac echocardiography (ice).Pericardiocentesis was performed to remove 400 ml of fluid from the pericardial space.The patient was reported to be in stable condition.There¿s no information regarding extended hospitalization, patient¿s outcome or physician causality opinion.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

Additional information was received on january 9, 2020 and it was reported that the cardiac tamponade was discovered after the mapping phase, while trying to remove a non-biosense webster, inc.Quad catheter out the coronary sinus to do further mapping, all under fluoroscopy and there was no contact force.Therefore, the physician opinion on the cause of the event is related to the maneuvering of the non-biosense webster, inc.Quad catheter.Patient¿s outcome was improved after pericardiocentesis was completed.Extended hospitalization was not required.There were no error messages observed on any biosense webster, inc.Equipment.Transseptal was not performed.No ablation was performed prior to discovering the effusion.Additionally, the initial reporter/physician information was provided, as such, the appropriate fields in section e.Have been populated.Manufacturer's reference # (b)(4).

Manufacturer Narrative

Additional information was received on (b)(6)2020 , and it was noted that the biosense webster, inc., thermocool® smart touch® sf bi-directional navigation catheter was used for mapping prior to the effusion being discovered.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference # (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9402428
• MDR Text Key: 168831880
• Report Number: 2029046-2019-03948
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention