MAUDE Adverse Event Report: BIOSENSE WEBSTER, INC. (JUAREZ) 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number	D-1268-04-S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2016
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.Concomitant products: st.Jude medical sr0 8.5fr sheath, model and lot numbers unknown.Manufacturer's ref.No: (b)(4).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with an ez steer navigational 4mm catheter where the catheter had exposed wiring near electrode #3.Per the electrophysiologist, there was a small interruption in the insulation near the third electrode, exposing some of the internal wiring.It is not known if the damage resulted in any lifted or sharp rings.No difficulty was reported regarding insertion or removal of the catheter from the patient.The catheter was replaced, and the case was 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
On 1/4/2017, 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).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an ablation procedure with an ez steer navigational 4 mm catheter where the catheter had exposed wiring near electrode #3.The returned device was visually inspected, and no exposed wire was found near the third electrode.This catheter is designed with an anchor window and t-bar located near electrode #3, both of which are covered by polyurethane.Per the reported event, the catheter outer diameters were measured and found within specification.During the manufacturing process, all catheters are inspected for visual damage before packaging.This catheter was manufactured according to the specifications and process instructions.The device history record (dhr) was reviewed, and no anomalies were found related to this complaint.In addition, the dhr review verified 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: 7F ES STEER DS BI-DIRECTIONAL NAV CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER, INC. (JUAREZ); circuito interior norte #1820; parque industrial salvacar; juarez, chihuahua 32599 ; MX 32599
• MDR Report Key: 6217112
• Report Number: 9673241-2017-00001
• Device Sequence Number: 13583406
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: (01)10846835003031(11)160415(17)190331(10)17452339M
• Combination Product (Y/N): N
• PMA/510(K) Number: P990025/S12
• 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): 12/08/2016

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: 03/31/2019
• Device Model Number: D-1268-04-S
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 17452339M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/08/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 01/02/2017
• Supplement Report FDA Received Date: 01/04/2017; 02/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1