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

Model Number D134805

Device Problems High Readings (2459); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)

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

Event Date 10/08/2020

Event Type  Injury  

Manufacturer Narrative

"no code available" is being used to represent surgical intervention.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 (b)(6) male patient with history of transcatheter aortic valve replacement (tavr) and cancer, underwent a right sided premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the mapping phase with the stsf catheter there was a drop in the patient¿s blood pressure, and cardiac tamponade was confirmed by intracardiac ultrasound.Pericardiocentesis was performed to drain the fluid from the pericardial space and the blood was auto infused back into the patient.The patient was then transferred to the operating room for surgical repair of the right ventricle outflow tract (rvot) laceration.Extended hospitalization was required as a result of the event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.Transseptal puncture was not performed during the case.No ablation was performed prior to the event.Default irrigation settings were used during mapping.High force readings were observed during the procedure.The force visualization features used included dashboard and vector.The high force issue is not mdr-reportable.The cardiac tamponade is mdr-reportable since the event is life threatening and required surgical intervention and prolonged hospitalization to prevent permanent impairment of a body function or permanent damage to a body structure.

Manufacturer Narrative

On (b)(6) 2020, the product investigation was completed.It was reported that a 72-year-old male patient with history of transcatheter aortic valve replacement (tavr) and cancer, underwent a right sided premature ventricular contraction (pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis and surgical intervention.During the mapping phase with the stsf catheter there was a drop in the patient¿s blood pressure, and cardiac tamponade was confirmed by intracardiac ultrasound.Pericardiocentesis was performed to drain the fluid from the pericardial space and the blood was auto infused back into the patient.The patient was then transferred to the operating room for surgical repair of the right ventricle outflow tract (rvot) laceration.Extended hospitalization was required as a result of the event.Patient¿s condition improved.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.Device evaluation details: the device was visually inspected and it was found in good conditions.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 1106 was observed.A failure analysis was performed, the catheter was dissected and the sensor values were found within specifications, with this information, the failure can be attributed to a potential pc board failure.Then, the catheter was connected at the cool flow pump and the catheter did not irrigate, an aluminum wire was introduced in the luer hub and the wire got stuck in dome.The dome was dissected, and it was found material causing partially the occlusion.Further investigation revealed foreign material occluding part of the dome.A fourier transform infrared spectroscopy test (ftir) was performed and the results showed foreign material is primarily composed of a biological-based material, presumably human tissue or fluid.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.A manufacturing record evaluation was performed for the finished device 30384676m number, and no internal actions related to the reported complaint condition were identified the customer complaint cannot be confirmed.Physician¿s opinion regarding the cause of the adverse event is that it was procedure and patient condition related.The root cause of the adverse event remains unknown.The root cause of the pc board failure and the occlusion in dome, cannot be determined, it could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.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: 10793390
• MDR Text Key: 215490737
• Report Number: 2029046-2020-01631
• 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
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/03/2021
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30384676M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2020
• Date Manufacturer Received: 12/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR