MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Model Number D128211

Device Problems Signal Artifact/Noise (1036); Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/08/2021

Event Type  malfunction  

Manufacturer Narrative

Device evaluation details: the device was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and electrical evaluation of the returned device.Visual analysis of the returned pentaray nav high-density mapping eco catheter revealed that electrodes #14, #15 and #16 were found misshaped and lifted.Electrical test was performed, and the device failed, no electrical readings were observed on electrodes #014 and #016.A failure analysis was performed and the device was dissected on the tip area.The electrical wires were found broken causing the improper electrical signal.Manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.As part of biosense webster¿s quality process all devices are manufactured, inspected, and released to approved specifications.The instructions for use contain the following warning stated in the carto 3 system manual: ecg noise is typically generated as the result of improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify proper connection.It is recommended to turn off the notch filter for this verification.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

A patient underwent a cardiac ablation procedure with a pentaray nav high-density mapping eco catheter for which biosense webster¿s product analysis lab (pal) identified electrodes damaged during product analysis.It was initially reported by the customer that there was a loss of signals/egms on poles 13-14 and 15-16.Troubleshooting followed delaying the procedure only a few minutes.They changed the cable without change.They changed the catheter and issue was fixed.There was no patient consequence.The customer¿s reported issue signal noise/loss affecting some channels of the body surface (bs, 12-lead) is not considered to be mdr reportable since the risk to the patient is low.On 27-jul-2021, the bwi product analysis lab received the complaint device for evaluation.On (b)(6) 2021, pal revealed that a visual inspection of the device found electrodes #14, #15 and #16 were misshaped and lifted.These findings were determined to be an mdr reportable malfunction.This event was originally considered non-reportable, however, bwi became aware of a reportable malfunction through product analysis on (b)(6) 2021 and reassessed it as mdr reportable.

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12558747
• MDR Text Key: 282417941
• Report Number: 2029046-2021-01649
• Device Sequence Number: 1
• Product Code: MTD
• UDI-Device Identifier: 10846835012255
• UDI-Public: 10846835012255
• Combination Product (y/n): N
• PMA/PMN Number: K123837
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 09/30/2021

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: 03/11/2024
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30534999L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2021
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PENTARAY NAV ECO 7FR, D, 2-6-2