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 Arrhythmia (1721); Cardiac Arrest (1762)

Event Date 08/01/2020

Event Type  Injury  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered hear block and cardiac arrest requiring resuscitative measures.Transseptal was performed under ultrasound with a soundstar catheter and during mapping in the left atrium with the pentaray catheter, the patient developed cardiac arrest and interrupted the maneuver temporarily.During cardiac arrest, cardiac massage and pacing from the ventricle catheter were performed.Ablation was resumed after the patient¿s condition stabilized and pulmonary vein isolation (pvi) isolation was performed until the procedure was completed.The physician¿s commented that the patient seemed to have left bundle branch block.Although the cause was unknown, the patient might have developed right bundle branch block, which led to cardiac arrest.There was no report of extended hospitalization.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.Should more information become available in the future; the reportability decision will be reassessed.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with thermocool® smart touch® sf bi-directional navigation catheter and suffered hear block and cardiac arrest requiring resuscitative measures.Transseptal was performed under ultrasound with a soundstar catheter and during mapping in the left atrium with the pentaray catheter, the patient developed cardiac arrest and interrupted the maneuver temporarily.During cardiac arrest, cardiac massage and pacing from the ventricle catheter were performed.Ablation was resumed after the patient¿s condition stabilized and pulmonary vein isolation (pvi) isolation was performed until the procedure was completed.The physician¿s commented that the patient seemed to have left bundle branch block.Although the cause was unknown, the patient might have developed right bundle branch block, which led to cardiac arrest.On 9/1/2020, biosense webster inc.Received additional information about the patient and event.It was reported the patient in this procedure was a female weighing 60 kg.The adverse event was discovered during use of bwi products and the physician¿s opinion on the cause of the adverse event is patient¿s condition.Device evaluation details: on 9/10/2020, the complaint product was returned to biosense webster inc.¿s (bwi) product analysis lab (pal) for evaluation and device evaluation has been completed.The device was visually inspected and it was found in good conditions.The temperature features were tested and no issues were observed.In addition, the catheter was deflecting and irrigating correctly.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 106 was observed.A failure analysis was performed and the catheter was dissected on the tip area, loss of electrical continuity at the sensor was found, it was determined that the root cause was an internal failure of the sensor.A manufacturing record evaluation was performed and no internal action related to the complaint was found during the review.The root cause of the adverse event remains unknown.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The force issue (error 106) identified during testing is highly detectable by the system; however, improvements have been implemented to reduce magnetic and force sensor internal issues.All units are inspected prior leaving the facility and the mre verified that this complaint unit was in good condition.Correction: it was noticed the concomitant products were inadvertently omitted from the 3500a initial medwatch report.The devices have now been added to field d11.Concomitant med products if additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 10463954
• MDR Text Key: 204704837
• Report Number: 2029046-2020-01131
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 08/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30376719M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 09/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Weight: 60