MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER P030031/S053; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	UNKNOWN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant bwi products include: stockert j70 rf generator (us catalog # s7036, serial # (b)(4)).(b)(6).(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with an unspecified thermocool® smart touch¿ bi-directional navigation catheter.It was reported that during the procedure ablation was stopped by an ¿impedance to high¿ error message.When the catheter was remove from the patient¿s body, clotting was found stuck to the tip of the catheter.The clotting was wiped off and flushing was conducted to continue with the procedure.It was then found that the setting selection on the generator was wrong, a non-irrigation setting was selected in spite of using an irrigation catheter.The procedure was completed normally.No patient consequences were reported.The issue of impedance to high error message is not a reportable event.However, the clot found attached to the tip of the catheter is reportable.

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER P030031/S053
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7441406
• Report Number: 2029046-2018-01445
• Device Sequence Number: 16434285
• Product Code: LPB
• UDI-Device Identifier: 10846835009170
• UDI-Public: 10846835009170
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/20/2018
• Initial Report FDA Received Date: 04/18/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1