MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER NAV DS; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number	BN7TCFJ8L
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a ez steer nav ds and some of the blue coating stretched out and the wiring was exposed when the catheter was taken out of the body.It was between the distal and proximal electrodes of the catheter.There were no lifted nor sharp rings.The physician did not mention any resistance or difficulty.The catheter was replaced to continue the procedure.No adverse patient consequence was reported.
Additional 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).
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial flutter (afl) ablation procedure with a ez steer nav ds and some of the blue coating stretched out and the wiring was exposed when the catheter was taken out of the body.It was between the distal and proximal electrodes of the catheter.There were no lifted nor sharp rings.The physician did not mention any resistance or difficulty.The catheter was replaced to continue the procedure.No adverse patient consequence was reported.Device investigation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection of the returned device was performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device, no wires or internal components were observed exposed.A manufacturing record evaluation was performed for the finished device number lot 31262146m and no internal action related to the complaint was found during the review.The internal components exposed 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.The instructions for use (ifu) contain the following recommendations: the sterile packaging and catheter should be inspected prior to use.Do not use the catheter if the packaging or catheter appears damaged.As part of johnson & johnson medtech¿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 DS
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 20231155
• Report Number: 2029046-2024-03108
• Device Sequence Number: 15612772
• Product Code: OAD
• UDI-Device Identifier: 10846835003048
• UDI-Public: (01)10846835003048(17)270219(10)31262146M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P010068/S6
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/11/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: BN7TCFJ8L
• Device Lot Number: 31262146M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/16/2024
• Supplement Report FDA Received Date: 10/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NGEN.; UNK SHEATH.
• Patient Sex: Unknown