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

Catalog Number	D160901
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.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 there was some resistance in the right atrium and the splines were "bunched up together".The physician noted resistance not within the sheath but within the atrium itself.An insertion tool had been used.When the medical team removed the catheter from the body, there was some cardiac tissue on one of the splines.The medical team was going to biopsy the tissue due to unrelated patient issues.No injury to the patient.The catheter had not been inspected for lifted or sharpened rings.The team continued using the same catheter after the tissue was removed.No patient consequences were reported.
Additional Manufacturer Narrative
On 23-feb-2026, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation ablation procedure with a octaray mapping catheter and there was some resistance in the right atrium and the splines were "bunched up together".The physician noted resistance not within the sheath but within the atrium itself.An insertion tool had been used.When the medical team removed the catheter from the body, there was some cardiac tissue on one of the splines.The medical team was going to biopsy the tissue due to unrelated patient issues.No injury to the patient.The catheter had not been inspected for lifted or sharpened rings.The team continued using the same catheter after the tissue was removed.No patient consequences were reported.Device evaluation details: the device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection was performed following j&j medtech procedures.Visual analysis revealed no damage or anomalies on the device.The splines were observed within specifications.A manufacturing record evaluation was performed for the finished device number lot 31800915l and no internal actions related to the complaint were found during the review.The foreign material issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of the 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 reference number: (b)(4).
Additional Manufacturer Narrative
Per internal review on 19-mar-2026, it was determined that there was no foreign body but instead, there was cardiac tissue on the splines.There was no serious injury to the patient.As a result, no reportable event occurred and this event was mistakenly reported.No further reports will be sent regarding this event.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: 24379578
• Report Number: 2029046-2026-00536
• Device Sequence Number: 10257967
• Product Code: MTD
• 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,Followup
• Report Date (Section B): 04/15/2026

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: D160901
• Device Lot Number: 31800915L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 03/19/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 03/16/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/28/2025
• 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: TRUPULSE GENERATOR.
• Patient Sex: Unknown