MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282CT
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/12/2017
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 (b)(6) female patient underwent an atrioventricular nodal reentry tachycardia procedure with a webster ® cs catheter with ez steer® technology and auto id and a noise issue occurred.A strong noise occurred on all electrocardiogram (ecg) channels, including the body surface and the intracardiac channels, on both the carto 3 and recording system.The physician did not have any clear ecg signal to monitor the patient¿s heart rhythm.The catheter was changed and the issue resolved.The procedure was completed with no patient consequence.This event is mdr reportable because lack of monitoring of cardiac rhythm while devices are intracardiac may pose a potential risk to the patient.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 04/16/2018.Device evaluation: it was reported that a patient (b)(6) year-old female patient underwent an atrioventricular nodal reentry tachycardia procedure with a webster ® cs catheter with ez steer® technology and auto id 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.No electrical malfunction was observed.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 cannot be confirmed.Manufacturer's ref.No: (b)(4).

• Brand Name: WEBSTER ® CS CATHETER WITH EZ STEER® TECHNOLOGY AND AUTO ID
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7171643
• Report Number: 2029046-2018-01001
• Device Sequence Number: 853682
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: (01)10846835002423(11)170405(17)200331(10)17663944M
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K090898
• 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
• Report Date (Section B): 12/13/2017

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: 03/31/2020
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 17663944M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Initial Date Received by Manufacturer: 12/13/2017
• Supplement Date Received by Manufacturer: 12/13/2017
• Initial Report FDA Received Date: 01/08/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR