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 Problem Cardiac Tamponade (2226)

Event Date 11/26/2019

Event Type  Injury  

Manufacturer Narrative

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 female patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a cardiac tamponade which required pericardiocentesis.During the procedure, the vizigo sheath was not recognized by the carto 3 system.The cable was exchanged without resolution.The carto 3 study was exited and the vizigo sheath was exchanged; however, the sheath could still not be visualized.The case was continued without vizigo functions.Also during the procedure, a cardiac tamponade was diagnosed via an echocardiogram.A pericardiocentesis was performed by the physician.The patient was transferred to intensive care unit for observation and fully recovered.Extended hospitalization was not required.In the opinion of the physician the event was procedure related.Transseptal puncture was performed with the st.Jude brk xs needle.Prior to noting the effusion, ablation was performed.There was no evidence of steam pop.The irrigation setting was 15ml/min during ablation.No error messages were observed on the biosense webster equipment during the procedure.Graph, dashboard, vector and visitag features were used for force visualization.Visitag settings were 5mm for 3sec for stability and 3mm tags size.Time was used for coloring option.The recognition issue was assessed as not reportable.Since the device cannot be recognized by the carto 3 system, the user will not be able to use the device and will have to replace it.The most likely consequence was an intraprocedural delay.The potential risk that it could cause or contribute to a serious injury or death was remote.Since this cardiac tamponade may be life threatening; might result in permanent impairment of a body function or permanent damage to a body structure; or required medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure it is mdr reportable.

Manufacturer Narrative

Investigation summary: it was reported that a female patient underwent a paroxysmal atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, a cardiac tamponade was diagnosed via an echocardiogram.A pericardiocentesis was performed by the physician.The patient was transferred to intensive care unit for observation and fully recovered.Extended hospitalization was not required.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.In the opinion of the physician, the event was procedure related.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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: 9507246
• MDR Text Key: 188183515
• Report Number: 2029046-2019-04050
• 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
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2020
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30280123M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Date Manufacturer Received: 01/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ SMC; CARTO 3 SYSTEM; NON BWI - ST. JUDE BRK XS NEEDLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention