MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D131502
Medical Device Problem Code	No Display/Image (1183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer as such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool® sf nav uni-directional catheter and a loss of all ecg signals on all channels issue occurred.There were no patient consequences.Upon connection of the ablation catheter, signal interference occurred on all ecg signals on the carto and the recording system.Physician did not have any ecg signals available to monitor the patient¿s heart rhythm.Cable was replaced without resolution.Thermocool® sf nav uni-directional catheter was replaced and the issue resolved.Procedure continued without further incident or patient consequences.
Additional Manufacturer Narrative
It was reported that a patient underwent an ablation procedure for paroxysmal atrial fibrillation with a thermocool® sf nav uni-directional catheter and a loss of all ecg signals on all channels issue occurred.There were no patient consequences.The investigational analysis has been completed.The device was visually inspected, and it was found in good conditions.Magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, deflection test was performed, and it was found within specifications, the catheter was deflecting correctly.Then, a coolflow pump test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.The customer complaint cannot be confirmed.(b)(4).
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 8/13/2018.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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
On 9/10/2018, lot number (30023203l) was obtained and manufacture (2018-02-26) and expiration dates (2021-02-25 ) were received.Manufacturer's ref.No: (b)(4).

• Brand Name: THERMOCOOL® SF NAV UNI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 7714363
• Report Number: 2029046-2018-01839
• Device Sequence Number: 13785406
• Product Code: LPB
• UDI-Device Identifier: 10846835009248
• UDI-Public: 10846835009248
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P030031/S034
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/26/2018

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 Expiration Date: 02/25/2021
• Device Catalogue Number: D131502
• Device Lot Number: 30023203L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Initial Date Received by Manufacturer: 06/26/2018
• Supplement Date Received by Manufacturer: 08/13/2018; 09/11/2018; 09/11/2018
• Initial Report FDA Received Date: 07/24/2018
• Supplement Report FDA Received Date: 08/27/2018; 09/25/2018; 09/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1