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

Model Number BN7TCDF4L

Device Problem Separation Problem (4043)

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

Event Date 06/09/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with an ez steer nav bi-directional electrophysiology catheter and the catheter tip was bent, and per the doctor, the catheter broke and seemed to be lacking insulation.The catheter broke and bent at the tip but seemed to be lacking insulation (per the doctor¿s words).The bwi representative did see that it was physically bent between the distal and proximal electrode pairs.The physician used it with difficulty for most of the case, unsure if it broke part way through or if it was faulty.It was just bent at the tip between the distal and proximal electrodes not in two pieces.Unsure if the difficulty they had the whole time was due to it being bent or at what time in the procedure the bending occurred.There was no patient consequence.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The device evaluation was completed on 05-aug-2022.It was reported that a patient underwent a cardiac ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and the catheter tip was bent, and per the doctor, the catheter broke and seemed to be lacking insulation.The catheter broke and bent at the tip but seemed to be lacking insulation (per the doctor¿s words).The bwi representative did see that it was physically bent between the distal and proximal electrode pairs.The physician used it with difficulty for most of the case, unsure if it broke part way through or if it was faulty.It was just bent at the tip between the distal and proximal electrodes ¿ not in two pieces.Unsure if the difficulty they had the whole time was due to it being bent or at what time in the procedure the bending occurred.There was no patient consequence.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A microscopic examination was performed, and it confirmed that the tip is in good condition, no anomalies or damage were observed.The issue reported by the customer could not be replicated during the product investigation.Other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation (mre) was performed for the finished device number 30755559m, and no internal actions related to the complaint were found during the review.Based on the mre, the b4.Expiration date and h4.Device manufacture date have been updated.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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14940780
• MDR Text Key: 302679683
• Report Number: 2029046-2022-01527
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2022
• 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: 30755559M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2022
• 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