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 Consequences Or Impact To Patient (2199)
Date of Event	09/13/2016
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 atrioventricular nodal reentrant tachycardia procedure with an 7f es steer ds bi-directional nav catheter and the catheter tip was broken.When the catheter was removed from the patient, after some ablations had been done, something was on the tip of the catheter.The physician said it was not tissue or char but looked like a coating on the tip was peeling off.The material seemed to be part of the covering of the catheter.The catheter was replaced the case was continued and completed with no patient consequence.This event is mdr reportable because the risk to the patient is critical due to the potential of thrombus from exposure of internal catheter components, or due to risk of complete separation of the tip or tip component.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on (b)(6) 2016.The analysis has begun but is not completed at this time.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
(b)(4).It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia procedure with a 7f es steer ds bi-directional nav catheter and the catheter tip was broken.When the catheter was removed from the patient, after some ablations had been done, something was on the tip of the catheter.The physician said it was not tissue or char but looked like a coating on the tip was peeling off.The material seemed to be part of the covering of the catheter.The returned device was visually inspected and a light pink material was found on the tip of the catheter.A fourier transforms infrared spectroscopy (ft-ir) in order to identify the type of foreign material; the results demonstrated that the material had a biological nature.The catheter was reviewed and tip was found in good conditions; all rings were free of damage.No bents or sharp edges were observed.The catheter outer diameters were measured 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.The customer complaint regarding a foreign particle has been verified; however catheter was found within specifications.Based on available analysis finding results, the failure mode 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: 6014144
• Report Number: 9673241-2016-00685
• Device Sequence Number: 912302
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: (01)10846835003031(11)151029(17)180930(10)17350140M
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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): 09/13/2016

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: 09/30/2018
• Device Model Number: D-1268-04-S
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 17350140M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2016
• Was the Report Sent to FDA?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/13/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 10/10/2016
• Supplement Report FDA Received Date: 10/31/2016; 11/11/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1