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

Model Number	D160902
Medical Device Problem Codes	Device-Device Incompatibility (2919); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an unspecified ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and after gaining access to left ventricle via aortic valve using octaray there was resistance with sheath and stuck deflection.The physician elected to use an octaray catheter to map a pvc (premature ventricular contraction) expected to be from the left ventrilce based on the ecg (electrocardiogram) morphology.They reported some resistance from the sheath as the catheter sensor electrodes exited the sheath when inserting.The sheath was an 8 fr arrow braided sheath inserted into the right femoral artery.They mapped the aortic cusps without issue.When attempting to enter the left ventricle, they flexed the catheter to double back and use the heal of the catheter to cross the valve, as per their usual practice.They were able to cross the valve with the heal of the catheter but found when straightening the catheter that the catheter would not flex fully back to a fully straight position as desired to allow the catheter tip to enter the left ventricle.On pulling back to the aorta they were then unable to straighten the catheter, with the catheter conforming to the vessel wall, doubled back on itself.They were able to pull the catheter back to the descending aorta and use the catheter mechanism plus the sheath to straighten the catheter.On removal of the catheter, visual inspection appeared to show the catheter to flex and unflex correctly.However the physician explained that they were concerned that the catheter flexion was not working fully and this had made it more difficult to straighten the catheter inside the patient's aorta.The catheter was not placed back in the patient and instead an ablation catheter was used.No patient consequences were reported.Resistance with sheath is not mdr-reportable.Stuck deflection is mdr-reportable.
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 24-jun-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an unspecified ablation procedure with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and after gaining access to left ventricle via aortic valve using octaray there was resistance with sheath and stuck deflection.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, deflection and dimensional test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.A deflection test was performed, and the curve was deflecting within specifications.No deflection issues were observed.A dimensional test was performed, and the outer diameters of the device were found within specifications.A manufacturing record evaluation was performed for the finished device number lot 30948073l and no internal actions related to the complaint were found during the review.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).

• 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: 17026553
• Report Number: 2029046-2023-01176
• Device Sequence Number: 17860644
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 07/20/2023

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: 11/01/2023
• Device Model Number: D160902
• Device Catalogue Number: D160902
• Device Lot Number: 30948073L
• 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: 05/02/2023
• Supplement Date Received by Manufacturer: 07/20/2023
• Initial Report FDA Received Date: 05/30/2023
• Supplement Report FDA Received Date: 07/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2022
• 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 FR ARROW BRAIDED SHEATH.
• Patient Sex: Unknown