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

Catalog Number D134703

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/03/2023

Event Type  Injury  

Event Description

It was a reported that a patient underwent atrial fibrillation (afib) ablation procedure that included thermocool® smart touch® sf uni-directional navigation catheter.The patient experienced cardiac perforation that required surgical intervention.An adverse event was reported.Toward the end of the procedure when doing a cti line, there was a pericardial effusion that occurred.The patient's blood pressure dropped.The caller could not provide specific vital data.They noticed and confirmed a pericardial effusion was present on ice images.The soundstar catheter was utilized to confirm the effusion.The pericardiocentesis was performed and they "removed roughly 11,000 units" of fluids.The patient was transported to the operating room for surgery and the caller believes the patient is stable.The physician believes that a perforation occurred during their cti line ablation phase.They used the thermocool® smart touch® sf uni-directional navigation catheter, soundstar catheter, pentaray catheter, and the esophastar catheter during the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because 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.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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 17435417
• MDR Text Key: 320172541
• Report Number: 2029046-2023-01642
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009798
• UDI-Public: 10846835009798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/03/2023
• Initial Date FDA Received: 08/01/2023
• 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
• Treatment: UNK_ESOPHASTAR; UNK_PENTARAY; UNK_SOUNDSTAR
• Patient Outcome(s): Life Threatening; Required Intervention