MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY MAPPING CATHETER; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160904
Medical Device Problem Codes	Entrapment of Device (1212); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Rupture (2208)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The product was discarded, therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.Picture and video related to the event were provided by the customer.Evaluation is still in progress.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 ref.# (b)(4).
Event or Problem Description
It was reported that during a cardiac ablation mapping with octaray mapping catheter and the patient experienced an inability to remove the catheter, because it was stuck in the valve when trying to enter the right ventricle (rv) to map for ventricular tachycardia (vt).The catheter was released, but part of the valve was stuck on the catheter.It was reported that an octaray mapping catheter got stuck in the tricuspid valve when trying to enter rv to map a vt.The physician tried to progress the vizigo to release the catheter but it was not possible.Finally, the catheter was capable of being released, but part of the tricuspid valve was stuck in the catheter.The patient sustained consequence consisting of tricuspid valve insufficiency.No other medical intervention was noted.Multiple attempts have been made to gain clarification and additional information about this event with no response.Should any new information be obtained, it will be assessed and processed accordingly.
Additional Manufacturer Narrative
It was reported that during a cardiac ablation mapping with octaray mapping catheter and the patient experienced an inability to remove the catheter, because it was stuck in the valve when trying to enter the right ventricle (rv) to map for ventricular tachycardia (vt).The catheter was released, but part of the valve was stuck on the catheter.It was reported that an octaray mapping catheter got stuck in the tricuspid valve when trying to enter rv to map a vt.The physician tried to progress the vizigo to release the catheter but it was not possible.Finally, the catheter was capable of being released, but part of the tricuspid valve was stuck in the catheter.The patient sustained consequence consisting of tricuspid valve insufficiency.No other medical intervention was noted.Device investigation details: a video was received for evaluation following johnson & johnson medtech's procedures.According to the video provided by the customer, quick movement in the splines can be observed on the carto 3 system screen.Also, the splines could not be seen to be expanded; however, a stuck condition cannot be confirmed based on the video provided.Also, an additional photo provided shows a white material which could be biological material, as per the information provided by the customer a part of the tricuspid valve was stuck in the catheter.A manufacturing record evaluation was performed, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the video received.The device has not been returned for analysis and a root cause is unable to be assigned based on the current evidence.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 photo and 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).

• Brand Name: OCTARAY MAPPING CATHETER
• Common Device Name: CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY
• 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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22736631
• Report Number: 2029046-2025-02604
• Device Sequence Number: 9120811
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(11)250426(17)260425(10)31640537L
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K193237
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/25/2026
• Device Catalogue Number: D160904
• Device Lot Number: 31640537L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/10/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/26/2025
• 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: UNK_CARTO VIZIGO SHEATH.
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown