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

Model Number R7D282CT

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

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

Event Date 06/14/2023

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 31005463m and no internal action related to the complaint was found during the review.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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an svt (superventricular tachycardia) ablation procedure with a decanav electrophysiology catheter and the number 5 electrode on decanav was blacked out, and there was noise present on carto3 and ep recording system.To troubleshoot, the medical team re-seated the cable, and the issue persisted; the physician refused to replace the catheter and continue with the case and completed the case successfully.No patient consequences were reported.Visualization issue is not mdr-reportable.Bad/ no ecg all channels (bs and ic) is mdr-reportable.

Manufacturer Narrative

On 8-feb-2024, the product investigation was completed.It was reported that a patient underwent an svt (superventricular tachycardia) ablation procedure with a decanav electrophysiology catheter and the number 5 electrode on decanav was blacked out, and there was noise present on carto3 and ep recording system.To troubleshoot, the medical team re-seated the cable, and the issue persisted; the physician refused to replace the catheter and continue with the case and completed the case successfully.No patient consequences were reported.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection, magnetic sensor functionality and electrical evaluation 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; however, a black electrode was observed.Afterwards; an electrical test was performed, and an open circuit was found in the tip area.A manufacturing record evaluation was performed for the finished device number lot 31005463m and no internal action related to the complaint was found during the review.Since a black electrode was detected, both issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.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).

Manufacturer Narrative

On (b)(6) 2024, the bwi 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.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: 17304086
• MDR Text Key: 319117598
• Report Number: 2029046-2023-01484
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835008791
• UDI-Public: 10846835008791
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/04/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2024
• Device Model Number: R7D282CT
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31005463M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/03/2023
• 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: CARTO 3 SYSTEM