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

Model Number	D-1313-05-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/11/2017
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 noise issue occurred.Noise from all body surface and all intracardiac channels was being displayed on the carto 3 system and on the recording system.The cable was replaced with no resolution.When the catheter was replaced, the issue resolved.The procedure was completed with no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available this event is mdr reportable because the inability to monitor the patient¿s ecg rhythm while devices are intra cardiac might lead to undetected cardiac rhythm that could be life threatening.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 04/17/2017.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
Manufacturer's ref.No: (b)(4).It was reported that a patient underwent an atrial fibrillation procedure with a thermocool® sf nav bi-directional catheter and a noise issue occurred.The returned device was visually inspected and it was found in normal conditions.Per the event, the catheter was tested for electrical performance and it was found 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.During manufacturing process all the catheters are inspected for visual damages before packaging.On line inspections and functional tests are in place to prevent this type of damage from leaving the facility.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: 6306198
• Report Number: 9673241-2017-00090
• Device Sequence Number: 817559
• Product Code: LPB
• UDI-Device Identifier: 10846835003208
• UDI-Public: (01)10846835003208(11)160826(17)190731(10)17555474L
• Combination Product (Y/N): N
• PMA/510(K) Number: P030031/S025
• 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
• Report Date (Section B): 01/13/2017

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: 07/31/2019
• Device Model Number: D-1313-05-S
• Device Catalogue Number: BNI35DFCT
• Device Lot Number: 17555474L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 02/06/2017
• Supplement Report FDA Received Date: 04/24/2017; 06/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1