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

Catalog Number R7D282CT

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Heart Block (4444)

Event Date 09/20/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure using soundstar eco 8fg ultrasound catheter and decanav electrophysiology catheter.The patient experienced heart block that required implantation of temporary pacemaker.The patient developed transient heart block during the procedure.This occurred prior to any ablation and prior to transseptal access.Upon review of the study using the timeline feature, there were no catheters near the his/ atrioventricular (av) node.Prior to advancing the decanav and right ventricle (rv) quad catheters into the patient, there was right bundle branch block noted.The soundstar eco 8fg ultrasound catheter had already been advanced and was floating in the right atrium.After all the catheters were placed, a wire was advanced to the superior vena cava and the heart block was then noted.The physician is unsure how/why the heart block occurred.The patient was in af at the beginning of the procedure, so no av node interval measurements could be recorded.A temporary pacemaker was placed at this time.The patient was currently stable and intermittently in sinus rhythm, with a long pr interval.Biosense webster, inc.Products used was the webster quad, soundstar, and decanav.No ablation catheter had been in the body.Additional information was received.Physician's opinion on the cause of this adverse event was patient condition.Patient recovered.Other relevant medical history includes existing fascicular block.The adverse event was assessed conservatively reportable under both the soundstar eco 8fg ultrasound catheter and decanav electrophysiology catheter.

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.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure using decanav electrophysiology catheter.The patient experienced heart block that required implantation of temporary pacemaker.The bwi product analysis lab received the device for evaluation on 23-oct-2023.The device evaluation was completed on 27-oct-2023.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and revision of all features were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.The device features were reviewed and no issues were observed during the product investigation.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.The root cause of the adverse event remains unknown.In addition, no device malfunction was reported, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: 17957512
• MDR Text Key: 325945221
• Report Number: 2029046-2023-02355
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

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 Expiration Date: 05/11/2024
• Device Catalogue Number: R7D282CT
• Device Lot Number: 31062021M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/20/2023
• Initial Date FDA Received: 10/18/2023
• Supplement Dates Manufacturer Received: 10/23/2023
• Supplement Dates FDA Received: 11/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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: SOUNDSTAR ECO GE 8F CATHETER.; UNK WEBSTER QUAD CATHETER.
• Patient Outcome(s): Required Intervention; Life Threatening