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	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/12/2016
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.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 ablation procedure for atrial fibrillation with an ez steer thermocool sf nav catheter where clotting was found stuck to the tip.During the procedure, it was found that the catheter could not be flushed correctly.An examination of the catheter found that this is because of clotting that had become stuck to the tip.The catheter was replaced with another, and the procedure was completed without any patient consequence.There were no issues related to temperature or flow on the catheter.The generator was being used in power control mode, but there is no information regarding the power or temperature cutoff values.It was, however, noted that none of the cutoff values were reached.Temperature/power/impedance values at the time of the event are unknown.An anticoagulant was in use, but specific information is not available.The clotting was not specifically identified as char/clot/coagulum by the physician.The irrigation/flushing issue is not mdr reportable.However, the clotting that caused the irrigation/flushing issue is mdr reportable.Though the clotting substance was not identified, this event is being conservatively reported, as these substances exhibit poor adherence to catheters and transseptal sheaths, increasing the risk of embolism for the patient.
Additional Manufacturer Narrative
On 12/1/2016, the bwi failure analysis lab received the device for evaluation.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 reference number: (b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an ablation procedure for atrial fibrillation with an ez steer thermocool sf nav catheter where clotting was found stuck to the tip.The returned device was visually inspected, and the irrigation holes were found to be occluded with dark reddish brown material.However, during a second visual inspection, the same occlusion was not found.It is possible that the material was lost during the decontamination and/or shipping processes.Per the reported event, the catheter was tested for electrical performance, temperature response and generator compatibility, and it was found within specifications.An irrigation test was performed, which the catheter passed.No occlusion was observed.During the manufacturing process, all catheters are inspected for visual damage before packaging.On-line inspections are in place to prevent catheters with this type of damage from leaving the facility.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 regarding clotting has been verified.However, the root cause of the clotting remains unknown.

• 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: 6077042
• Report Number: 9673241-2016-00764
• Device Sequence Number: 1135987
• Product Code: LPB
• UDI-Device Identifier: 10846835003215
• UDI-Public: (01)10846835003215(11)131101(17)161031(10)15997113L
• 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): 10/21/2016

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: 10/31/2016
• Device Model Number: D-1317-05-S
• Device Catalogue Number: BNI35DFH
• Device Lot Number: 15997113L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 11/03/2016
• Supplement Report FDA Received Date: 12/05/2016; 02/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1