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

Model Number	D134803
Date of Event	09/04/2020
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
It was reported that a female patient ((b)(6)) underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported by the caller while ablating in the left atrium the catheter was not able to move freely and the ultrasound catheter showed a pericardial effusion that measured at 1.5 cm.The patient is stable.The physician feels the ablation catheter may have caused the pericardial effusion.The caller states the pericardiocentesis was performed.This adverse event was discovered during use of biosense webster products during ablation phase.The physician¿s opinion is that the cause of this adverse event is patient¿s condition.The patient had fully recovered after extended hospitalization (length of stay is unknown).Transseptal was performed (device unknown).Prior to noting the effusion ablation was performed.There was no evidence of steam pop.Irrigation setting was 15ml/min.No error messages were observed on biosense webster equipment during the procedure.Graph, dashboard, vector and visitag were used for force visualization.The visitag module settings were range 2mm, time 3sec, force over time (fot) 25%.There was no additional filter used with the visitag.Surpoint was used for color option.There was no device entrapment.Vizigo sheath was used.
Additional Manufacturer Narrative
It was reported that a female patient (83 year old, 104lb) underwent cardiac ablation procedure for atrial flutter (afl) with thermocool® smart touch® sf bi-directional navigation catheter and suffered cardiac tamponade requiring pericardiocentesis.It was reported by the caller while ablating in the left atrium the catheter was not able to move freely and the ultrasound catheter showed a pericardial effusion that measured at 1.5 cm.The patient is stable.The physician feels the ablation catheter may have caused the pericardial effusion.The caller states the pericardiocentesis was performed.This adverse event was discovered during use of biosense webster products during ablation phase.The physician¿s opinion is that the cause of this adverse evet is patient¿s condition.The patient had fully recovered after extended hospitalization (length of stay is unknown).Device evaluation details: the device evaluation has been completed.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 ref.#(b)(4).

• Brand Name: THERMOCOOL SMART TOUCH SF BI-DIRECTIONAL NAVIGATION CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10623836
• Report Number: 2029046-2020-01396
• Device Sequence Number: 11057405
• Product Code: LPB
• UDI-Device Identifier: 10846835010169
• UDI-Public: 10846835010169
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2020

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 06/01/2021
• Device Model Number: D134803
• Device Catalogue Number: D134803
• Device Lot Number: 30384576M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2020
• Initial Date Received by Manufacturer: 09/04/2020
• Supplement Date Received by Manufacturer: 10/09/2020
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No