MAUDE Adverse Event Report: BIOSENSE WEBSTER INC DECANAV ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number R7F282CT

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 05/18/2023

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster, inc., or its employees that the report constitutes an admission that the product, biosense webster, inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a bad/ no ecg all channels (bs and ic) issue occurred.It was reported that an error 7 ¿ current leakage error was displayed when the decanav catheter was plugged in.The patient interface unit was turned off for a few minutes and changed out the decanav catheter cable without resolution.The "current leakage error" was accompanied by a loss of all signal including ecg.The signal interference (noise/loss) was observed all ecg (bs + ic) channels.It was observed on both carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was not inside the patient¿s body.The decanav catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.The current leakage error is not mdr reportable.This issue 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 bad/no ecg all channels (bs and ic) is mdr reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a decanav electrophysiology catheter and a bad/ no ecg all channels (bs and ic) issue occurred.It was reported that an error 7 ¿ current leakage error was displayed wihen the decanav catheter was plugged in.The patient interface unit was turned off for a few minutes and changed out the decanav catheter cable without resolution.The "current leakage error" was accompanied by a loss of all signal including ecg.The signal interference (noise/loss) was observed all ecg (bs + ic) channels.It was observed on both carto® and recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was not inside the patient¿s body.The decanav catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation on 19-jun-2023.Visual inspection, magnetic sensor functionality, and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly.No magnetic issues or current leakage errors were observed.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation (mre) was performed for the finished device number lot 31007764m and no internal action related to the complaint were found during the review.Based on the completed mre, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated with appropriate information.The issues reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

• Brand Name: DECANAV ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17140081
• MDR Text Key: 318073983
• Report Number: 2029046-2023-01304
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008807
• UDI-Public: 10846835008807
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2024
• Device Model Number: R7F282CT
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31007764M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2023
• 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
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,; CBL,25 HYP/34 HYP,RED,10'; CBL,25 HYP/34 HYP,RED,10'; SOUNDSTAR ECO SMS 8F CATHETER; UNK_CARTO 3; UNK_ESOPHASTAR