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

Model Number D134804

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

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

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

The "no code available" patient code is being used to represent the surgical intervention and prolonged hospitalization.The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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 a cardiac ablation procedure for persistent atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention (pericardial window).During the procedure, a small pericardial effusion was noticed by intracardiac echocardiography (ice).The patient¿s blood pressure did not drop.After the ablation was complete, the attending attempted to place the ablator which was transseptal in the left atrium (la) and through a vizigo sheath which was back in the right atrium (ra) into the lv in order to v-pace to complete the study.Both the la and left ventricle (lv) were unusually large and getting into the lv was difficult.It was then noticed that the catheter slide above the mitral annulus area and advance out.There were atrial signals and the physician was advised to pull back because it was thought they were in the left atrial appendage (laa) (this was confirmed later with replay).The effusion then grew, and cardiac tamponade was confirmed by ice.Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.The patient required also a pericardial window.Extended hospitalization was needed as a result of the adverse event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.Transseptal puncture was done during the case.There was no evidence of steam pop during the ablation.Correct catheter irrigation settings were used.No error messages were observed on any equipment throughout the procedure.The force visualization features used included dashboard, vector and visitag.Standard surpoint stability parameters were used with the visitag module.Tag index was used as color option.Since this event is life threatening and required medical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

On 10/12/2020, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure for persistent atrial fibrillation (afib) with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention (pericardial window).During the procedure, a small pericardial effusion was noticed by intracardiac echocardiography (ice).The patient¿s blood pressure did not drop.After the ablation was complete, the attending attempted to place the ablator which was transseptal in the left atrium (la) and through a vizigo sheath which was back in the right atrium (ra) into the lv in order to v-pace to complete the study.Both the la and left ventricle (lv) were unusually large and getting into the lv was difficult.It was then noticed that the catheter slide above the mitral annulus area and advance out.There were atrial signals and the physician was advised to pull back because it was thought they were in the left atrial appendage (laa) (this was confirmed later with replay).The effusion then grew, and cardiac tamponade was confirmed by ice.Pericardiocentesis was performed to drain an unspecified amount of fluid from the pericardial space.The patient required also a pericardial window.Extended hospitalization was needed as a result of the adverse event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure related.Device evaluation details: 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 (ifu) 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).

• 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: 10577207
• MDR Text Key: 208306713
• Report Number: 2029046-2020-01312
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: 10846835010176
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/02/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30320531M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; UNK_TRANSEPTAL NEEDLE; VIZIGO SHEATH
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention