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

Catalog Number BN7TCDF4L

Device Problem Break (1069)

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

Event Date 03/01/2024

Event Type  malfunction  

Manufacturer Narrative

On 20-mar-2024, 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 nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and the catheter tip was dislocated.It was reported that the tip of the catheter looked dislocated on the flouro machine.The caller took the catheter out of the body and the tip was dislocated.When the catheter was replaced, the issue was resolved.No wires were exposed.There was no damage that resulted in lifted or sharp rings.There was no patient consequence.

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and the catheter tip was dislocated.It was reported that the tip of the catheter looked dislocated on the flouro machine.The caller took the catheter out of the body and the tip was dislocated.When the catheter was replaced, the issue was resolved.No wires were exposed.There was no damage that resulted in lifted or sharp rings.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed that the tip of the device has a bent mark.No wires were observed to be exposed.No other damager or anomalies were observed in the device.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.Based on the bent condition observed, this issue could be related to the issue reported; therefore, the customer complaint was confirmed.This issue could be related to the manipulation of the device during the procedure; however, this can not be conclusively determined.The instructions for use contain the following recommendations: do not use excessive force to advance or withdraw the catheter.Do not scrub or twist the tip electrode as damage may cause catheter failure or patient injury.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 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: 18976388
• MDR Text Key: 338711820
• Report Number: 2029046-2024-01018
• 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
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 31203585M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2024
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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: ABBOT AGILIS, 8.5F.