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

Catalog Number D134804

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Perforation (2513)

Event Date 07/12/2023

Event Type  Injury  

Manufacturer Narrative

Bwi note: reprocessed cs catheter captured in a separate complaint (manufacturer report number 2134070-2023-00019).The device has been reported as discarded, therefore 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 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.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 a patient underwent atrial fibrillation ablation procedure that included thermocool smarttouch sf catheter.The patient experienced pericardial effusion / cardiac tamponade that required pericardiocentesis.Timing: end of procedure / ablation.Description of health hazard: "it was reported by the medical team that the 9,10 electrodes of the reprocessed coronary sinus (cs) catheter were not displaying signals.The catheter cable was replaced without resolution.The catheter was replaced, and the issue resolved.It was also reported that the patient suffered a pericardial effusion.It was discovered post-ablation via a routine check with intracardiac echocardiography (ice) imaging.The patient did not have any signs or symptoms.A pericardiocentesis is currently being performed.The patient is currently stable.Transseptal puncture was performed (2) with baylis needle.Ablation was performed prior to noting pericardial effusion.No evidence of steam pop.Also, no impedance spikes noted during ablation.Irrigation catheter settings: 8/15 ml, per instructions for use (ifu).No error messages observed on biosense webster equipment during the procedure.Patient hemodynamically stable.Pericardiocentesis was performed.No evidence of any effusion present before the procedure.Outcome of the adverse event: unchanged.Amount of fluid removed: less than 180 ml.The procedure was not abandoned as the issue was discovered at end of procedure.Suspected perforation: coronary sinus.Other bwi products used during procedure: soundstar, sterilmed cs, pentaray, vizigo.Additionally, the medical team did not replace the catheter after the sensor error as "the sensor was not pivotal to the case".The medical team suspected that the cswas the cause because there was difficulty placing it back into the cs after it fell out mid case.Bwi note: reprocessed cs catheter captured in a separate complaint (manufacturer report number 2134070-2023-00019).However, cardiac perforation is being captured on the ablation catheter as well since ablation was performed.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious.

• 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: 17491995
• MDR Text Key: 320728697
• Report Number: 2029046-2023-01728
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/12/2023
• 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: BAYLIS NEEDLE; PENTARAY CATHETER; SOUNDSTAR CATHETER; STERILMED CS; VIZIGO SHEATH
• Patient Outcome(s): Required Intervention; Life Threatening