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

Catalog Number BN7TCDF4L

Device Problems Contamination /Decontamination Problem (2895); Device-Device Incompatibility (2919)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The biosense webster, inc.Product analysis lab received the device for evaluation.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.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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and during the procedure, the physician noticed that the 4mm nav catheter had a strange plastic film on the plastic tip.The physician was pulling pieces off the tip and blood and other substances were sticking to it.The catheter was replaced, and the issue was resolved.The procedure was continued with no patient consequence.Additional information was received.It was reported that the issue was not noticed before use.The catheter was not advancing very far up the sheath and so it was pulled out to be inspected and they noticed what seemed like a plastic coating or film around the tip of the ablation catheter.Some of the material was pulled off and the rest seemed to be adhered to the tip but could be slid up and down a bit.

Manufacturer Narrative

Additional information received on 11-apr-2024 indicated that the sheath that was used was a terumo pinnacle introducer 8fr sheath.Therefore, the concomitant product section was updated.On 30-apr-2024, the device evaluation was completed.It was reported that a patient underwent an atrioventricular nodal re-entrant tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and during the procedure, the physician noticed that the 4mm nav catheter had a strange plastic film on the plastic tip.The physician was pulling pieces off the tip and blood and other substances were sticking to it.The catheter was replaced, and the issue was resolved.The procedure was continued with no patient consequence.Additional information was received.It was reported that the issue was not noticed before use.The catheter was not advancing very far up the sheath and so it was pulled out to be inspected and they noticed what seemed like a plastic coating or film around the tip of the ablation catheter.Some of the material was pulled off and the rest seemed to be adhered to the tip but could be slid up and down a bit.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual and dimensional inspections of the returned device were performed in accordance with bwi procedures.Visual analysis revealed no damage nor any foreign material on the tip of the device.A dimensional inspection was performed, and the device passed within specification.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The resistance with sheath and foreign material issues reported by the customer could not be confirmed during the product investigation; 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 reference number:(b)(4) during an internal review on 26-apr-2024, it was noted that the h6.Medical device problem code of device-device incompatibility (b)(6) has not been assigned.Therefore, this code was added to this report.

• 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: 19078479
• MDR Text Key: 339806661
• Report Number: 2029046-2024-01175
• 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: 05/08/2024

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 Catalogue Number: BN7TCDF4L
• Device Lot Number: 31197808M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2023
• 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: TERUMO PINNACLE INTRODUCER 8FR SHEATH; UNK SHEATH