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

Catalog Number	D160904
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and after some ablation had been completed, and the medical team had re-inserted the octaray¿ catheter into the body, it was noticed that the tip of the octaray¿ catheter was not irrigating.The catheter was removed from the body and flushing was performed with a syringe.However, the catheter was occluded and no solution came out.The device was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.
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).
Additional Manufacturer Narrative
On 8-may-2025, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and after some ablation had been completed, and the medical team had re-inserted the octaray¿ catheter into the body, it was noticed that the tip of the octaray¿ catheter was not irrigating.The catheter was removed from the body and flushing was performed with a syringe.However, the catheter was occluded and no solution came out.The device was replaced and the issue was resolved.The procedure continued.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation and irrigation test of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed no damage or anomalies.An irrigation test was performed and the device was totally occluded.Further investigation revealed that the irrigation tube was found folded in the tip area.A manufacturing record evaluation was performed for the finished device 31532293l number, and no internal actions related to the reported complaint condition were identified.The irrigation issue reported by the customer was confirmed.The potential cause of the occlusion could be related to the manipulation of the device during the procedure; however, this can not be conclusively determined.The catheter instructions for use (ifu) contain the following recommendations: flush the catheter with heparinized normal saline prior to insertion into the body.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through j&j medtech 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).

• 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: 21972591
• Report Number: 2029046-2025-01447
• Device Sequence Number: 12797421
• Product Code: MTD
• UDI-Device Identifier: 10846835021233
• UDI-Public: (01)10846835021233(17)271217(10)31532293L
• 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
• Report Date (Section B): 06/02/2025

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 Catalogue Number: D160904
• Device Lot Number: 31532293L
• 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: 04/14/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/18/2024
• 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: FARAPULSE SYSTEM.
• Patient Sex: Unknown