MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number NS7TCFL174HS

Device Problems Break (1069); Manufacturing, Packaging or Shipping Problem (2975); Packaging Problem (3007)

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

Event Date 01/01/2023

Event Type  malfunction  

Manufacturer Narrative

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a navistar¿ electrophysiology catheter.Packaging of the device was slightly damaged before the device was taken out of the packaging (no exact information available about where and how the packaging was damaged).The medical team then took the device out of the packaging in order to check the device for possible defects, then during manipulation of the device, the customer noticed that the catheter tip is outside the socket and the cabling at the inside became visible.It can be assumed that the described defect is related to the damaged catheter packaging and the following manipulation of the device.It was then replaced with another catheter.No patient consequences were reported.

Manufacturer Narrative

On 16-jan-2024, the bwi 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

On 7-feb-2024, the product investigation was completed.It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a navistar¿ electrophysiology catheter.Packaging of the device was slightly damaged before the device was taken out of the packaging (no exact information available about where and how the packaging was damaged).The medical team then took the device out of the packaging in order to check the device for possible defects, then during manipulation of the device, the customer noticed that the catheter tip is outside the socket and the cabling at the inside became visible.It can be assumed that the described defect is related to the damaged catheter packaging and the following manipulation of the device.It was then replaced with another catheter.No patient consequences were reported.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection of the returned device was performed following bwi procedures.Visual analysis revealed that the tip was found broken.A detailed examination under the microscope was performed and internal parts were observed exposed.A manufacturing record evaluation was performed for the finished device 31135183m number, and no internal action related to the complaint was found during the review.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.The damage on the package was not able to analyzed, due to the package was not returned for analysis.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: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, ELECTRODE RECORDING
• 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: 18414273
• MDR Text Key: 331584828
• Report Number: 2029046-2023-03111
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2024

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: NS7TCFL174HS
• Device Lot Number: 31135183M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/01/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/16/2024; 02/07/2024
• Supplement Dates FDA Received: 02/05/2024; 03/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2023
• 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