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

Catalog Number	D160904
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 27-may-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.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 atrial fibrillation (afib) ablation procedure with a vizigo and an octaray mapping catheter and a stringy thrombus was found on both devices.It was reported that when the withdrew the octaray mapping catheter from the vizigo sheath there was stringy thrombus adhered to the octaray splines and inside the sheath at the port part of the hemostatic valve.Caller did not know if the thrombus in that area of the sheath due to the catheter being pulled out.Caller replaced the sheath due to no longer being able to aspirate.No injury to the patient.
Additional Manufacturer Narrative
It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a vizigo and an octaray mapping catheter and a stringy thrombus was found on both devices.It was reported that when the withdrew the octaray mapping catheter from the vizigo sheath there was stringy thrombus adhered to the octaray splines and inside the sheath at the port part of the hemostatic valve.Caller did not know if the thrombus in that area of the sheath due to the catheter being pulled out.Caller replaced the sheath due to no longer being able to aspirate.No injury to the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection, microscopic examination, and irrigation test of the returned device were performed in accordance with j&j procedures.Visual analysis revealed no damage or anomalies on the device.The customer reported that there was stringy thrombus adhered to the splines after withdrew the octaray catheter; however, during the analysis in the lab, no thrombus, or clot residues were observed.A microscopic examination of the spline was performed, but no damage or anomalies were identified on the device.Finally, an irrigation test was performed and the device was flushing correctly, no obstructed hole was observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The thrombus/clot issue reported by the customer could not be confirmed, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instruction for use (ifu) contains the following warnings and precautions: to avoid char formation on the rings of this mapping catheter, do not apply rf energy when the ablation catheter is in contact with one or more rings of the mapping catheter.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 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: 22137573
• Report Number: 2029046-2025-01806
• Device Sequence Number: 15234501
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(17)280219(10)31585005L
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: 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: D160904
• Device Lot Number: 31585005L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/03/2025
• Supplement Report FDA Received Date: 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/20/2025
• 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: 8.5F SHEATH WITH CURVE VIZ MDC.; SPLIT HANDLE EXT. CABLE,10' LG.; UNK_CARTO 3.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown