MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number BN7TCDF4L

Device Problem Break (1069)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

On 31-jan-2023, the bwi product analysis lab received the complaint device for evaluation.The product 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/wolff-parkinson-white syndrome (wpw) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and the catheter tip was broken.It was reported by the bwi representative that during a procedure when taking the catheter out of its packaging the catheter looked damaged.They reported that a "chunk of the catheter was missing around the tip" and a "wire was sticking out of the end".To troubleshoot the catheter was replaced, the issue was resolved, and the procedure was continued.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter, damage was noticed so not inserted.The issue was found between electrodes 2 and 3.Catheter was not pre-shaped.Sheath used was a prelude psi, merit 7fr.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular reentrant tachycardia (avrt)/wolff-parkinson-white syndrome (wpw) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and the catheter tip was broken.It was reported by the bwi representative that during a procedure when taking the catheter out of its packaging the catheter looked damaged.They reported that a "chunk of the catheter was missing around the tip" and a "wire was sticking out of the end".To troubleshoot the catheter was replaced, the issue was resolved, and the procedure was continued.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection.Visual analysis of the returned sample revealed no biological material was found, and no physical damage was observed.Only an anchor window between electrodes 2 and 3 which is part of the design of this device.Polyurethane is applied on the anchor window.The event described about the broken tip, could not be confirmed as the device performed without any issues.Although no issues were identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the complaint were found during the review.As part of bwi¿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 ref.# (b)(4).

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 16291316
• MDR Text Key: 308758403
• Report Number: 2029046-2023-00216
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025/S12
• 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: 02/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30877744M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2023
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2022
• 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: PRELUDE PSI, MERIT 7FR SHEATH.