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

Model Number BN7TCDF4L

Device Problems Contamination /Decontamination Problem (2895); Material Twisted/Bent (2981)

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

Event Date 03/08/2021

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 3/29/2021.The 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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an av-nodal reentrant tachycardia (avnrt) ablation procedure with ez steer¿ nav bi-directional electrophysiology catheter and foreign material was observed on the usable length of the catheter.Initially it was reported when the catheter was removed from patient, it was noticed that the catheter tip was physically damaged.The damage was described as the catheter tip was kinked between the second electrode and the third electrode.The catheter was replaced and the issue was resolved.The catheter tip kinked/bent was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Additional information was received on the event on 3/25/2021.The tip was bent where the sensor was inserted and there was clear resin over top just distal to the 3rd electrode.No wires were exposed and the damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the catheter.The catheter was not pre-shaped.The bent tip remains assessed as not mdr reportable.The described ¿resin over the top just distal to the 3rd electrode¿ was assessed as mdr reportable for ¿foreign material on the usable length of the catheter¿.The awareness date for this information is 3/25/2021.

Manufacturer Narrative

Initially in the 3500a it was reported that the tip was bent where the sensor was inserted and there was clear resin over top just distal to the 3rd electrode.This event was assessed as not mdr reportable for catheter tip kinked/bent and reportable for the foreign material observed on the usable length of the catheter.However, during the product investigation, no foreign matter was observed and the area that the customer was describing was the anchor window.Therefore, per the product investigation completion on 4/28/2021, it was determined that the reported issue is related to the anchor window of the catheter which is not a product deficiency but a product design.Since it was assessed that there was no product deficiency, the foreign material-on usable length of catheter has been removed and this complaint is only for the not reportable tip kinked/bent issue and therefore, processed the reportability from malfunction to not mdr reportable.The awareness date for this reassessment to not mdr reportable is 4/28/2021.The device evaluation was completed on 4/28/2021.The customer is explaining the area where the bent was observed.It is not complaining about any foreign material.The area that the customer is describing is the anchor window and this is part of the catheter design.The product was returned to biosense webster for evaluation.Bwi conducted visual inspection and tilt test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the ez steer nav catheter.The electrodes were inspected and no damage was found.No foreign material was found inside the device.The tilt test was performed, in accordance with bwi procedures.The tip was found within specifications.A manufacturing record evaluation was performed for the finished device batch number, and internal actions were identified.As part of bwi¿s quality process all devices are manufactured, inspected, and released to approved specifications.It should be noted that product failure is multifactorial.The event described could not be confirmed as the device performed without any issues.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the laboratory analysis.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: EZ STEER NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11615144
• MDR Text Key: 243908840
• Report Number: 2029046-2021-00502
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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 Expiration Date: 11/05/2023
• Device Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Device Lot Number: 30466605M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Manufacturer Received: 03/25/2021
• Initial Date FDA Received: 04/05/2021
• Supplement Dates Manufacturer Received: 04/28/2021
• Supplement Dates FDA Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND CATHETER