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

Model Number BN7TCDF4L

Device Problems Material Twisted/Bent (2981); Mechanical Jam (2983)

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

Event Date 12/23/2022

Event Type  malfunction  

Manufacturer Narrative

Device investigation details: a picture was received for evaluation following biosense webster's procedures.According to pictures provided by the customer, the tip of the catheter was observed with a bent condition, this condition is related to the customer complaint; however, at this time it is not possible to determine the root cause of this condition.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the picture received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.No capa will be initiated based on the available information and results of the investigation.If the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the video analysis results.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 supraventricular tachycardia (svt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter wherein the deflection mechanism became stuck.It was reported that the ez steer¿ nav bi-directional electrophysiology catheter¿s tip was bent, and the catheter was stuck in the f curve position.The ez steer¿ nav bi-directional electrophysiology catheter was replaced and the issue resolved.The procedure continued.There was no patient consequence.Additional information was received indicating the tip of the catheter was permanently deflected in the f curve although it may not be fully deflected.When the catheter is deflected to the d curve the tip is still deflected in the f curve.The knob can be turned, and the shaft of the catheter will deflect but the distal tip of the catheter is stuck in the f deflection.There was no difficulty in removing the catheter.There was no ring, electrode or other physical damage observed at the distal end of the catheter.Sheath used was abbott swartz 8.5f sr0 sheath.

Manufacturer Narrative

On 27-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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an supraventricular tachycardia (svt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter wherein the deflection mechanism became stuck.It was reported that the ez steer¿ nav bi-directional electrophysiology catheter¿s tip was bent, and the catheter was stuck in the f curve position.The ez steer¿ nav bi-directional electrophysiology catheter was replaced and the issue resolved.The procedure continued.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.Visual inspection and deflection test of the returned device were performed following bwi procedures.A picture was received from the customer on which the tip seemed bent; however, the visual analysis of the returned device revealed no damage in the tip.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.As an additional test a tilt test was performed and the device was inside the tolerance specifications.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint condition were identified.The tip was measured and it is within the manufacturing tolerance specification therefore, customer complaint cannot be confirmed.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.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: 16219432
• MDR Text Key: 309028308
• Report Number: 2029046-2023-00136
• 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,Followup
• Report Date: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 30921122M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/23/2022
• Initial Date FDA Received: 01/20/2023
• Supplement Dates Manufacturer Received: 01/27/2023; 03/01/2023
• Supplement Dates FDA Received: 02/17/2023; 03/15/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 4MM NAVIGATIONAL BI-DIRECT; ABBOTT SWARTZ 8.5F SR0 SHEATH