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

Catalog Number R7F282CT

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

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

Event Date 11/13/2023

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.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 flutter (afl) ablation procedure with a decanav electrophysiology catheter and the carto 3 system was displaying an error 7,"current leakage error", and there was noise on the decanav, as well as on the body surface signals.The noise was also on the recording system.The cable was replaced without resolution.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Initially, this event was assessed as not mdr reportable.However, on 15-nov-2023, additional information was received stating that there were no intact electrocardiogram (ecg) signals while the decanav was connected and while the catheter was in the coronary sinus (cs).When the bad catheter was disconnected, the ecg signals returned to both carto and recording system.A new cable did not fix this issue and so the catheter was then replaced.The additional information received makes this event mdr reportable product malfunction with an awareness date of 15-nov-2023.

Manufacturer Narrative

The device evaluation was completed on 05-jan-2024.It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a decanav electrophysiology catheter and the carto 3 system was displaying an error 7,"current leakage error", and there was noise on the decanav, as well as on the body surface signals.The noise was also on the recording system.The cable was replaced without resolution.When the catheter was replaced, the issue was resolved, and the procedure was continued.No adverse patient consequence was reported.Initially, this event was assessed as not mdr reportable.However, on 15-nov-2023, additional information was received stating that there were no intact electrocardiogram (ecg) signals while the decanav was connected and while the catheter was in the coronary sinus (cs).When the bad catheter was disconnected, the ecg signals returned to both carto and recording system.A new cable did not fix this issue and so the catheter was then replaced.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A 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.The device was connected to the carto 3 system, and it was recognized and visualized correctly.No issues or errors were observed.Afterward, an electrical test was performed, and no noise issues were found.A manufacturing record evaluation (mre) was performed for the finished device 31138998m number, and no internal actions related to the reported complaint condition were identified.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 issue 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.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: 18314850
• MDR Text Key: 330466616
• Report Number: 2029046-2023-02925
• Device Sequence Number: 1
• Product Code: DRF
• 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: 01/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31138998M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/05/2023
• 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: UNK BRAND CABLE.; UNK BRAND CABLE.; UNK_CARTO 3.