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

Catalog Number	BNI35DFH
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/27/2018
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.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a thermocool® sf nav bi-directional catheter.A thrombus formation was observed on the thermocool® sf nav bi-directional catheter tip.There were no patient consequences.There is no evidence of neurological signs or symptoms since the procedure was completed.There is no information regarding generator parameters or generator settings.There were no catheter issues related to temperature or flow.System did not present any error messages.Physician did not report any product problems.There is no information regarding anticoagulant being used during the procedure.
Additional Manufacturer Narrative
The biosense webster inc.Failure analysis lab received the device for evaluation on 8/27/2018.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
Investigation summary: it was reported that a patient underwent an ablation procedure with a thermocool® sf nav bi-directional catheter.A thrombus formation was observed on the thermocool® sf nav bi-directional catheter tip.There were no patient consequences.There is no evidence of neurological signs or symptoms since the procedure was completed.The device was visually inspected and it was found in good conditions.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, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.Then, irrigation test was performed and it was found within specifications, the catheter was irrigating correctly, no irrigation issues were observed.Then, magnetic sensor functionality was tested on carto and the catheter failed, error 105 was observed.A failure analysis was performed, the catheter was dissected and the sensor values were found within specifications, with this information, the failure can be attributed to a potential pc board failure.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.On line, functional tests are in place to prevent this type of failure from leaving the facility.Manufacturer's reference #: (b)(4).

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7793731
• Report Number: 2029046-2018-01970
• Device Sequence Number: 1510463
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: 10846835003215
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P030031/S025
• 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,Followup,Followup
• Report Date (Section B): 07/27/2018

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: BNI35DFH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 08/27/2018; 10/23/2018
• Initial Report FDA Received Date: 08/17/2018
• Supplement Report FDA Received Date: 08/28/2018; 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1