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

Catalog Number	D160906
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On 26-aug-2025, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and during the remap phase of the procedure, and (after successfully performing a first map, the device could not be flushed at all with the heparinized nacl solution.There were no errors noted prior to discovering the issue.Also, as flushing was being made, irrigation would not go through catheter.All troubleshooting was done, but the bwi irrigation tube was switched for a new one with no success.Irrigation was done through the pump to check if the pump was functioning, which it was.The issue was only solved by replacing with a new octaray catheter.There were no consequences for the patient.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.A visual inspection and irrigation test of the returned device were performed in accordance with j&j medtech procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device.An irrigation test was performed, and irrigation could not be performed, therefore, dissection was performed in the tip area and the irrigation tube was found folded.A manufacturing record evaluation was performed for the finished device number lot 31112240l, and no internal actions related to the reported complaint were identified.The issue reported by the customer was confirmed.The potential cause of the irrigation tube bent could not be conclusively determined.As part of johnson & johnson medtech's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech's quality system.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
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).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and during the remap phase of the procedure, and (after successfully performing a first map, the device could not be flushed at all with the heparinized nacl solution.There were no errors noted prior to discovering the issue.Also, as flushing was being made, irrigation would not go through catheter.All troubleshooting was done, but the bwi irrigation tube was switched for a new one with no success.Irrigation was done through the pump to check if the pump was functioning, which it was.The issue was only solved by replacing with a new octaray catheter.There were no consequences for the patient.
Additional Manufacturer Narrative
On 6-aug-2025, bwi received additional information indicating that there were no visible errors/issues on the complaint device.Additionally, on 19-aug-2025, the bwi 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.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: 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: 22534501
• Report Number: 2029046-2025-02372
• Device Sequence Number: 15306116
• Product Code: MTD
• UDI-Device Identifier: 10846835021134
• UDI-Public: (01)10846835021134(11)230712(17)240711(10)31112240L
• Combination Product (Y/N): N
• Initial Reporter Country: PO
• 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,Followup
• Report Date (Section B): 09/16/2025

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: 07/11/2024
• Device Catalogue Number: D160906
• Device Lot Number: 31112240L
• 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: 06/19/2025
• Supplement Date Received by Manufacturer: 08/06/2025; 08/26/2025
• Initial Report FDA Received Date: 07/17/2025
• Supplement Report FDA Received Date: 08/26/2025; 09/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/12/2023
• 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
• Patient Sex: Unknown