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

Catalog Number	D134803
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Complete Heart Block (2627); No Code Available (3191)
Date of Event	10/02/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The biosense webster inc.Product analysis lab received the device for evaluation on 10/15/2019.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 ref.No: (b)(4).
Event or Problem Description
It was reported that a male patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a heart block av which required a permanent implantable pacemaker.During the procedure, a junctional escape rhythm was observed and a heart block was discovered.The temporary pacemaker was set.The patient was reported to be in stable condition and a 24 hour hold had been put on to see if the node would reinitiate activity.The permanent pacemaker was to be set if no activity was seen during the 24 hour hold.The permanent pacemaker was implanted the next day.The patient required extended hospital stay and permanent damage was sustained by the av node requiring a permanent implantable pacemaker.The adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event is that it was related to procedure while ablating a flutter in the left atrium near the left atrial septum.
Additional Manufacturer Narrative
Investigation summary: it was reported that a male patient underwent an atrial fibrillation (afib) procedure with a thermocool® smart touch® sf bi-directional navigation catheter.During the procedure, a junctional escape rhythm was observed and a heart block was discovered.The temporary pacemaker was set.The patient was reported to be in stable condition and a 24 hour hold had been put on to see if the node would reinitiate activity.The permanent pacemaker was to be set if no activity was seen during the 24 hour hold.The permanent pacemaker was implanted the next day.The patient required extended hospital stay and permanent damage was sustained by the av node requiring a permanent implantable pacemaker.The adverse event was discovered during use of biosense webster products.The device was visually inspected and it was found in good conditions.The magnetic sensor was tested on carto and the catheter was properly visualized and no errors were observed.Then, the force sensor was tested and it was working properly, the force values were observed within specifications.Then, electrical test was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Then, the irrigation and deflection test was performed and it was found within specifications, the catheter was irrigating and deflecting correctly.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
During an internal review on december 3, 2019, a correction was noted on the patient codes.It was assessed to add the patient code of ¿surgical intervention¿ therefore, ¿no code available¿ was added to : patient code.Patient code of ¿no code available¿ represents ¿surgical intervention." manufacturer¿s reference number: (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: 9236778
• Report Number: 2029046-2019-03814
• Device Sequence Number: 19316613
• 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,Followup
• Report Date (Section B): 10/02/2019

1 Device was Involved in the Event

1 Patient 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: 05/12/2020
• Device Catalogue Number: D134803
• Device Lot Number: 30220578L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2019
• Initial Date Received by Manufacturer: 10/02/2019
• Supplement Date Received by Manufacturer: 11/04/2019; 12/03/2019
• Initial Report FDA Received Date: 10/25/2019
• Supplement Report FDA Received Date: 11/27/2019; 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6FR CS,F,10 POLE,12 PIN, AUTOID; 71CM TRANSSEPTAL NEEDLE; LASSO NAV 2515,12P SPLITHANDLE; SOUNDSTAR ECO SMS 8F CATHETER
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability