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	10/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device investigation details: a video was received for evaluation following johnson & johnson medtech's procedures.According to the video provided by the customer, the pouch of the device indicates that the curvature of the catheter is a fj curve; however, the engraving on the handle of the device indicates an df curvature.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint were identified.The customer complaint was confirmed based on the video received.The device has not been returned for analysis if the device is received in the future, the product investigation will be performed and updated accordingly, and any action will be taken if necessary.Note: h6.Investigation findings code of ¿appropriate term/code not available (c22)¿ used to represent the video analysis results.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Event or Problem Description
During an electrophysiology procedure at the hospital procor, the doctor requested to open the product bidirectional irrigated ablation catheter ez steer thermocool tc curve jf 7,5f, reference bdi75tcfjrt.When opening the indicated product, we found that it was not the correct item.Instead, we find a product specifying df curve, inside the package, belonging to the lot 31081511m.It is important to note that the df catheter is designed for smaller curve techniques, while the jf is used for larger curve techniques, which can significantly impact procedures.
Additional Manufacturer Narrative
On 14-jan-2025, 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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).
Additional Manufacturer Narrative
During an electrophysiology procedure at the hospital procor, the doctor requested to open the product bidirectional irrigated ablation catheter ez steer thermocool tc curve jf 7,5f, reference bdi75tcfjrt.When opening the indicated product, we found that it was not the correct item.Instead, we find a product specifying df curve, inside the package, belonging to the lot 31081511m.It is important to note that the df catheter is designed for smaller curve techniques, while the jf is used for larger curve techniques, which can significantly impact procedures.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection and deflection test of the returned device were performed.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; a deflection test was performed and it was noted that the curvature was a fj.A manufacturing record evaluation was performed and no internal actions related to the reported complaint condition were identified.The incorrect label issue reported by the customer was confirmed.The root cause of the issue was traced to the 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.Internal actions are being performed to investigate the incorrect label 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: 20631649
• Report Number: 2029046-2024-03599
• Device Sequence Number: 8144436
• Product Code: OAD
• UDI-Device Identifier: 10846835002898
• UDI-Public: (01)10846835002898(17)260712(10)31081511M
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,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 Expiration Date: 07/12/2026
• Device Catalogue Number: BDI75TCFJRT
• Device Lot Number: 31081511M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2024
• Supplement Date Received by Manufacturer: 01/14/2025; 02/07/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 01/16/2025; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/13/2023
• 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: EZ STEER TCOOL NONNAV TC F-J.; EZ STEER TCOOL NONNAV TC F-J.
• Patient Sex: Unknown