MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
Medical Device Problem Codes	Signal Artifact/Noise (1036); Pacing Problem (1439)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: 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.The customer complaint cannot be confirmed.  concomitant product: non biosense webster, inc.- biotronik pacing stimulator.Manufacturer's ref.No:(b)(4).
Event or Problem Description
It was reported that a patient underwent a procedure with a navistar¿ electrophysiology catheter.During the procedure, there was noise on the navistar¿ electrophysiology catheter.It was also reported that when pacing, the catheter paced through all channels.The catheter was replaced and the issues resolved.There was no patient consequence reported.Additional information was received stating that the pacing leads were connected to the primary pacing port.There was unwanted pacing being delivered as the system paced through all the channels at the same time.No ablation was performed before replacing the navistar¿ electrophysiology catheter.The biotronik pacing stimulator was being used during the procedure.The noise issue was assessed as not reportable.Ecg noise was only indicated on the navistar¿ electrophysiology catheter.Therefore,the risk to the patient was low.The pacing issue was assessed as a reportable malfunction.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7272239
• Report Number: 2029046-2018-01152
• Device Sequence Number: 13954743
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: P990025
• 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
• Report Date (Section B): 11/06/2017

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: 07/31/2020
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 17709984M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/06/2017
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1