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 Problems Cardiac Tamponade (2226); No Code Available (3191)

Event Date 06/18/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluation summary: the device was visually inspected and it was found in good conditions.The magnetic, temperature and force features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed and no internal actions related to the reported complaint were identified.The catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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 an (b)(6)-year-old female patient ((b)(6) lbs) underwent a right sided atrial flutter (r-afl) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the ablation, a steam pop on the junction of the inferior vena cava and right atrium occurred.The patient¿s blood pressure dropped, and cardiac tamponade was confirmed by ultrasound.Interventional cardiologist was called in to place a pericardiocentesis drain which was successfully placed, but persistent filling of pericardium required surgical intervention.Ct surgeon was called in to perform sternotomy and repair the perforation directly.Patient¿s condition improved.Extended hospitalization was required due to the adverse event and extent of surgical intervention.The patient was transferred to the intensive care unit (icu) for recovery and observation.Physician¿s opinion regarding the cause of the adverse event is that it was patient condition related.Transseptal puncture was performed with an abbott/st jude medical ¿ brk-1 (71cm) and brk-1 (98cm).Flow rate was at default setting of 8ml/min for smart touch sf catheter.No error messages were observed on any biosense webster, inc.Equipment.The force visualization features used included graph, dashboard and vector.The parameters for stability used with the visitag module were range: 2.5mm time: 3s, fot: 25% min 3g and tag size: 3mm.

• 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 10286667
• MDR Text Key: 199271441
• Report Number: 2029046-2020-00887
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/18/2020

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 Expiration Date: 12/09/2020
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30324367M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/18/2020
• Initial Date FDA Received: 07/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2019
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 84 YR
• Patient Weight: 59