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

Catalog Number R7F282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/13/2023

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.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 during an atrial fibrillation and atrial tachycardia case involving a decanav catheter, a blood cot was noticed in the patient's right atrium and required intervention to be removed.The blood cot in the right atrium was discovered and confirmed with intracardiac echocardiography (ice).The bwi devices that were in the right atrium at the time, were the soundstar catheter, decanav catheter, octaray catheter, and vizigo sheath.The clot was located around the coronary sinus catheter and detected while physician was working in the left atrium.The patient's act (activated clotting time) was 380 initially, and the second act was 400.Interventional radiology was called in, and interventional radiology used an angiojet in order to remove the blood cot from the patient.The patient was reported to be in stable condition and not exhibiting any neurological symptoms.No device issues reported and standard settings were utilized.Although multiple devices were being utilized, the reporter stated that the clot location was in proximity to the coronary sinus catheter, and the decanav catheter is the only catheter listed that can be utilized in the coronary sinus.

Manufacturer Narrative

On 18-oct-2023, the product investigation was updated with a manufacturing record evaluation.A manufacturing record evaluation was performed for the finished device number lot 31101385m and no internal action related to the complaint was found during the review.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: 17918066
• MDR Text Key: 325444355
• Report Number: 2029046-2023-02293
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: R7F282CT
• Device Lot Number: 31101385M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/13/2023
• Initial Date FDA Received: 10/12/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/11/2023
• 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: OCTARAY CATHETER; SOUNDSTAR CATHETER; UNSPECIFIED GENERATOR; VIZIGO SHEATH
• Patient Outcome(s): Life Threatening; Required Intervention