MAUDE Adverse Event Report: BIOSENSE WEBSTER INC OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE; CATHETER, INTRACARDIAC MAPPING, HIGH-DENSITY ARRAY

Catalog Number	D160902
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and constant alarms were received to indicate an occlusion.Liquid did not seem to enter the catheter as the liquid backed up in the drip chamber.The drip is set at 120 ml/h initially.The medical team tried to reduce the speed of the drip in several rounds, even down to 35 ml/h, but without improvement.The octaray was removed on two occasions to check for a blockage, but the occlusion alarms persisted even when the device was removed from the patient's body.Saline would not drip from the catheter at all.No further information was provided regarding resolution of the issue or if the procedure was completed.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.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
On 5-dec-2023, the product investigation was completed.It was reported that a patient underwent an atrial fibrillation (afib) paroxysmal ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and constant alarms were received to indicate an occlusion.Liquid did not seem to enter the catheter as the liquid backed up in the drip chamber.The drip is set at 120 ml/h initially.The medical team tried to reduce the speed of the drip in several rounds, even down to 35 ml/h, but without improvement.The octaray was removed on two occasions to check for a blockage, but the occlusion alarms persisted even when the device was removed from the patient's body.Saline would not drip from the catheter at all.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.Visual inspection and patency test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.A manufacturing record evaluation was performed for the finished device 31129990l number, and no internal actions related to the reported complaint condition were identified.The 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 biosense webster¿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 reference number: (b)(4).The product receipt was mistakenly omitted from initial report.The bwi product analysis lab received the device for evaluation on 29-nov-2023.

• Brand Name: OCTARAY, GALAXY, 48P, 2-5-2-5-2, D-CURVE
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18242027
• Report Number: 2029046-2023-02793
• Device Sequence Number: 7191662
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/02/2024

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: 08/14/2024
• Device Catalogue Number: D160902
• Device Lot Number: 31129990L
• 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: 11/04/2023
• Supplement Date Received by Manufacturer: 12/05/2023
• Initial Report FDA Received Date: 11/30/2023
• Supplement Report FDA Received Date: 01/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/15/2023
• 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