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

Model Number D128211

Device Problem No Display/Image (1183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/29/2019

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter wherein a current leakage error was displayed and all electrocardiogram (ecg) signals were lost.During the ablation procedure, it was reported that while using the pentaray nav high-density mapping eco catheter, an error code 7 was displayed.Additional information was received on december 5, 2019 confirming that during the interference the "ecg" and pentaray nav high-density mapping eco catheter signals were flat.The physician did not have any ecg signals available to monitor the patient¿s heart rhythm.The interference was only observed on the carto® 3 system.The catheter was replaced, and the issue was resolved.There was no patient consequence reported.The current leakage error and the procedure delay are to be considered non-mdr reportable since the potential risk that any of these could cause or contribute to a death or serious deterioration in state of health is remote.The loss of all ecg signals has been assessed as mdr reportable.On december 19, 2019, the biosense webster, inc.Product analysis lab received the device for evaluation, and it was noted that upon initial visual inspection, there was no damages or anomalies that were observed.

Manufacturer Narrative

Investigation summary : it was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a pentaray nav high-density mapping eco catheter wherein a current leakage error was displayed and all electrocardiogram (ecg) signals were lost.During the ablation procedure, it was reported that while using the pentaray nav high-density mapping eco catheter, an error code 7 was displayed.Additional information was received on december 5, 2019 confirming that during the interference the "ecg" and pentaray nav high-density mapping eco catheter signals were flat.The physician did not have any ecg signals available to monitor the patient¿s heart rhythm.The interference was only observed on the carto® 3 system.The catheter was replaced, and the issue was resolved.There was no patient consequence reported.The device was visually inspected, and it was found in good condition.Then, magnetic sensor functionality was tested on carto and the catheter was properly visualized and no errors were observed.Then, electrical testing was performed, and the catheter failed.No electrical readings were observed on electrode # 3.A failure analysis was performed, and the catheter was dissected on the tip area, the electrical wire was found broken causing the improper electrical signal.A manufacturing record evaluation was performed for the finished device with lot number 30237937l, and no internal actions related to the reported complaint condition were identified.The customer complaint has been verified.The root cause of the wire breakage cannot be related to the manufacturing process, since there is evidence that the device was manufactured in accordance with documented specification and procedures.It could be related to the handling of the device during the procedure, however, this cannot be conclusively determined.Manufacturer's reference # (b)(4).

• Brand Name: PENTARAY NAV HIGH-DENSITY MAPPING ECO CATHETER
• Type of Device: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 9531892
• MDR Text Key: 200058773
• Report Number: 2029046-2019-04074
• 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,Followup
• Report Date: 11/29/2019

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: 06/11/2022
• Device Model Number: D128211
• Device Catalogue Number: D128211
• Device Lot Number: 30237937L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/28/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM