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

Model Number	D-1317-05-S
Health Effect - Clinical Code	Thrombus (2101)
Date of Event	07/12/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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.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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® sf nav bi-directional catheter and a clot was observed on the catheter.During the ablation, a clot or coagulum was observed in conjunction with high impedance.The system did stop ablation when the high impedance cut off value was exceeded.There were no errors reported on the biosense webster systems during the procedure.In addition, there were no issues with temperature or flow on the catheter.The generator was in power mode.The issue was resolved by changing the catheter to another one.The procedure was completed without patient consequence.This event is mdr reportable because clot/coagulum has poor adherence to catheters and transseptal sheaths and it could be a potential source of embolism.The high impedance issue is not mdr reportable because the generator stopped ablation, therefore the potential that the high impedance could cause or contribute to a death, serious injury, or other significant adverse event is remote.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 08/05/2016.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.(b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool sf nav bi-directional catheter and a clot was observed on the catheter.During the ablation, a clot or coagulum was observed in conjunction with high impedance.The returned device was visually inspected upon receipt and it was found in normal conditions.A clot was not observed on the device.Per the event, the catheter was tested for electrical performance, temperature response and stockert compatibility and it was found within specifications.An irrigation test was performed and the catheter passed, no occlusion was observed.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.

• Brand Name: THERMOCOOL® SF NAV BI-DIRECTIONAL CATHETER
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 5845528
• Report Number: 9673241-2016-00474
• Device Sequence Number: 721828
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: (01)10846835003215(11)160125(17)181231(10)17401982L
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/13/2016

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: 12/31/2018
• Device Model Number: D-1317-05-S
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 17401982L
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 07/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/03/2016
• Supplement Report FDA Received Date: 08/22/2016; 09/06/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1