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

Catalog Number NS7TCFL174HS

Device Problems Signal Artifact/Noise (1036); Pacing Problem (1439)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2017

Event Type  malfunction  

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 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
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7272239
• MDR Text Key: 100282414
• Report Number: 2029046-2018-01152
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/06/2017
• Initial Date FDA Received: 02/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1