MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Model Number BD710FJ282CT

Device Problem Break (1069)

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

Event Date 10/31/2022

Event Type  malfunction  

Manufacturer Narrative

On 21-nov-2022, 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 atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and a broken tip issue occurred.It was reported that the distal tip of the a webster ® cs catheter with ez steer¿ technology was bent, and it looked like a piece of metal was poking out of the side of the tip.Bwi representative stated this was discovered right out of the package.The catheter was replaced and the issue resolved.The damage did not result in wires being exposed and did not result in any lifted or sharp rings.The issue was found proximal to electrode 2 from the distal end of the catheter.The catheter was not pre-shaped.Damage was noticed before attempting to place in the patient¿s body.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a webster ® cs catheter with ez steer¿ technology and a broken tip issue occurred.It was reported that the distal tip of the a webster ® cs catheter with ez steer¿ technology was bent, and it looked like a piece of metal was poking out of the side of the tip.Bwi representative stated this was discovered right out of the package.The catheter was replaced and the issue resolved.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.The returned device's visual inspection was performed following bwi procedures.Visual analysis was performed, and no broken tip was observed, the reported issue could be related to the anchor window, it was observed a polyurethane (pu) application between the electrodes.No exposed internal parts or malfunctions were observed.The issue reported by the customer could not be replicated during the product investigation.A manufacturing record evaluation was performed for the finished device, and no internal action was found during the review.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: WEBSTER ® CS CATHETER WITH EZ STEER¿ TECHNOLOGY
• Type of Device: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 15868182
• MDR Text Key: 307898423
• Report Number: 2029046-2022-02980
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: 10846835002423
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090898
• 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: 01/10/2023

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: BD710FJ282CT
• Device Catalogue Number: BD710FJ282CT
• Device Lot Number: 30859612M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/31/2022
• Initial Date FDA Received: 11/28/2022
• Supplement Dates Manufacturer Received: 12/16/2022
• Supplement Dates FDA Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/29/2022
• 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
• Treatment: BI DIR 7FR DEF CS,F-J,12 PIN