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

Model Number	D-1315-02-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.(b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool sf nav catheter where metal was exposed between the second and third electrodes.Prior to insertion of the catheter, the physician saw a copper-looking color in between the two electrodes, and noted that it appeared that the internal wiring was exposed.The physician chose not to use the catheter, and replaced it with another.The case continued without any report of patient consequence.Exposure to the internal components of the catheter presents a critical risk of thrombus to the patient.As a result, this event is mdr reportable.
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an ablation procedure for idiopathic ventricular tachycardia with a thermocool sf nav catheter where metal was exposed between the second and third electrodes.The returned device was visually inspected, and an electrical wire was observed between rings 2 and 3.However, it was covered by polyurethane, and no part of the wire was exposed.Per these conditions, the catheter outer diameters were measured, and were found within specifications.In addition, the catheter was tested for electrical performance, and it was found within specifications.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 catheter was manufactured according to specifications, and the visible wire between rings 2 and 3 is part of the catheter design.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 has been verified, but the catheter is within specifications.Based on available analysis finding results, the failure mode reported does not appear to be caused by any internal bwi processes.

• Brand Name: THERMOCOOL® SF NAV UNI-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: 6216562
• Report Number: 9673241-2016-00935
• Device Sequence Number: 18845090
• Product Code: LPB
• UDI-Device Identifier: 10846835009248
• UDI-Public: (01)10846835009248(11)150506(17)180430(10)17233084L
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 12/05/2016

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: 04/30/2018
• Device Model Number: D-1315-02-S
• Device Catalogue Number: D131502
• Device Lot Number: 17233084L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/30/2016
• Supplement Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1