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	Signal Artifact/Noise (1036); Device Contamination with Body Fluid (2317); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a atrial fibrillation (afib) with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and when the octaray was pulled out of the patient's body for replacing with the tv catheter after performing the lpv (left anterior carina and box ablation (both at 50 w), 2 or 3 electrodes on octaray were confirmed to be turned black and the chars were attached.When the electrodes were gently wiped, the chars could be wiped off.The exact timing of the occurrence was not identified.However, because there were a few interference noises on octaray and the qdot catheter during the ablation of the lpv anterior carina and the roof (total 3 lesion) on the review after the procedure, and the char issue might occurred at that time.The physician noticed the event when octaray was pulled out from the patient's body.No irrigation issues were confirmed.Also, the temperature was not displayed """"high"""" during ablation.Ablation time did not exceed 60 seconds (per an ablation).Ablation time did not exceed 120 seconds (per an ablation).Mean cf (contact force) value exceeded 25g sometimes (the exact values were unknown).Irrigation setting was within the recommended range.The setting of pre rf time and post rf time: pre 4s, post 2s.The physician mentioned the chars had been attached to the proximal and distal side of the tip electrode, but it was uncertain because there were no pictures.Power setting was 50w.The procedure was completed without patient's consequence.Bad/ partial ecg (bs or ic) is not mdr-reportable.Char is not mdr-reportable.Thrombus/clot is mdr-reportable.
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.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 31-may-2023, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent a atrial fibrillation (afib) with a octaray, galaxy, 48p, 2-5-2-5-2, d-curve and when the octaray was pulled out of the patient's body for replacing with the tv catheter after performing the lpv (left anterior carina and box ablation (both at 50 w), 2 or 3 electrodes on octaray were confirmed to be turned black and the chars were attached.When the electrodes were gently wiped, the chars could be wiped off.The exact timing of the occurrence was not identified.However, because there were a few interference noises on octaray and the qdot catheter during the ablation of the lpv anterior carina and the roof (total 3 lesion) on the review after the procedure, and the char issue might occurred at that time.Device evaluation details: visual analysis revealed char/thrombus on two of the electrodes of the device.A patency test was performed, and the device was flushing correctly, no obstructed holes were observed.No irrigation issues were observed.Afterward, an electrical test was performed, and no electrical issues were found a manufacturing record evaluation was performed for the finished device 30915359l number, and no internal actions related to the reported complaint condition were identified.The char/thrombus issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.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: 16994817
• Report Number: 2029046-2023-01138
• Device Sequence Number: 7039464
• Product Code: MTD
• UDI-Device Identifier: 10846835021110
• UDI-Public: 10846835021110
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 06/26/2023

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: 09/20/2023
• Device Model Number: D160902
• Device Catalogue Number: D160902
• Device Lot Number: 30915359L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/28/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/24/2023
• Supplement Report FDA Received Date: 06/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2022
• 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: NGEN GENERATOR (M685306, 22440132FC); NGEN PUMP (D139704, 091021-104); QDOT MICRO (D1395050, LOT 30918777L
• Patient Sex: Unknown