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

Catalog Number	BDI75TCFJRT
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 4-sep-2024, 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.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent an av node ablation procedure with a ez steer thermocool and packaging for the ez steer thermocool catheter showed it was an fj curve but the catheter had "df" printed on the actual catheter handle.It was reported that the packaging for the ez steer thermocool catheter showed it was an fj curve, but after opening the packaging, it was noticed that the ez steer thermocool catheter had "df" printed on the actual catheter handle, and the ez steer thermocool catheter was a df curve, not an fj curve.The procedure continued just using the ez steer thermocool df curve catheter.There was no patient consequence.
Additional Manufacturer Narrative
It was reported that a patient underwent an av node ablation procedure with a ez steer thermocool and packaging for the ez steer thermocool catheter showed it was an fj curve but the catheter had "df" printed on the actual catheter handle.It was reported that the packaging for the ez steer thermocool catheter showed it was an fj curve, but after opening the packaging, it was noticed that the ez steer thermocool catheter had "df" printed on the actual catheter handle, and the ez steer thermocool catheter was a df curve, not an fj curve.The procedure continued just using the ez steer thermocool df curve catheter.There was no patient consequence.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Visual inspection of the returned device was performed following j&j procedures.Visual analysis revealed that the rocker arm of the device was printed as df curve; however, the handle was printed as fj curve.The box sales unit was not return for analysis; however, the device was connected to the carto 3 system and it was recognized by the system as a ez steer thermocool non nav 4mm catheter, df.Also, a deflection test was performed and it was noted that the curvature is a df.Corrective and preventive action (capa) was opened to continue the investigation, and actions will take to address this issue.A manufacturing record evaluation was performed for the finished device batch number, and no non-conformances were identified.The label issue reported by the customer was confirmed.The root cause of the issue traced to manufacturing process.The instructions for use contain the following warnings and precautions: the sterile packaging and catheter should be inspected prior to use.Using aseptic technique, remove the catheter from the package and place it in a sterile work area.Inspect the catheter carefully for electrode integrity and overall condition.This product issue will be addressed through johnson & johnson medtech quality system.An internal action was created to further to investigate the ez steer engraving process issues.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: EZ STEER THERMOCOOL
• 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: 20208570
• Report Number: 2029046-2024-03065
• Device Sequence Number: 7745984
• Product Code: OAD
• UDI-Device Identifier: 10846835002898
• UDI-Public: (01)10846835002898(17)270606(10)31351661M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P030031
• 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
• Type of Report: Initial,Followup

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: BDI75TCFJRT
• Device Lot Number: 31351661M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 12/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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 GENERATOR.
• Patient Sex: Unknown