MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV ECO 7FR, D, 2-6-2 CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number D128211

Device Problems Device Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/27/2017

Event Type  Malfunction  

Manufacturer Narrative

No device was received for analysis at the time of submission of the initial 3500a. 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. The device history record (dhr) for the lot number 17750921l has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures. (b)(4).

Event Description

It was reported that a patient underwent a procedure with a pentaray nav high-density mapping eco catheter. It was reported that a current leakage alert was displayed on the system. The catheter was replaced and the procedure continued. No patient consequences were reported. Additional information was received which clarified that the current leakage error was displayed due to a signal noise issue. The signal noise was observed on all channels on the carto 3 system and the recording system. It was also confirmed that the physician did not have any ecg signal available to monitor the patient¿s heart rhythm. The current leakage alert was assessed as not reportable as it is highly detectable and requires adjusting system components to continue with the procedure. Devices may require reset or replacing but cannot be used on the patient. Patient safety is unaffected by this issue. The signal noise issue was assessed as a reportable malfunction.

• Brand Name: PENTARAY NAV ECO 7FR, D, 2-6-2
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: 7212467
• MDR Text Key: 98287360
• Report Number: 2029046-2018-01089
• Device Sequence Number: 1
• Product Code: MTD
• Combination Product (Y/N): N
• Reporter Country Code: TW
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: COMPANY REPRESENTATIVE,FOREIG

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/28/2017

1 Device Was Involved in the Event

0 PatientS WERE Involved in the Event:

• Date FDA Received: 01/23/2018
• Is This An Adverse Event Report?: No
• Is This A Product Problem Report?: Yes
• Device Operator: HEALTH PROFESSIONAL
• Device EXPIRATION Date: 10/16/2020
• Device Catalogue Number: D128211
• Device LOT Number: 17750921L
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 02/27/2018
• Is The Reporter A Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 12/28/2017
• Was Device Evaluated By Manufacturer?: Yes
• Date Device Manufactured: 10/17/2017
• Is The Device Single Use?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial