MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE¿ IRRIGATION TUBING SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_SMARTABLATE PUMP TUBING

Device Problems Improper or Incorrect Procedure or Method (2017); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/19/2023

Event Type  malfunction  

Event Description

Initially the event was reported under the 3500a initial mfr # 2029046-2024-00191 for product code d139702 (ngen pump) and the tubing set was processed as an ¿unknown tubing set¿ under the ¿d10.Concomitant medical products and therapy dates¿ section.Additional information was received on 05-feb-2024 stating the tubing set was the ngen pump tubing.However, does not have the specific tubing product information.States, it was probably a biosense webster, inc.Product and would verify.Due to the additional information provided on 05-feb-2024, the device was added to the complaint file as a bwi ¿unk_smartablate pump tubing¿ and the assessment was made to also report this event under this bwi device.The awareness date for this device is 05-feb-2024.It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a ngen pump and an unk_ smartablate¿ irrigation tubing set.A fire issue occurred.It was reported that saline solution got on the ngen pump ac adapter and the ac adapter caught on fire.The ngen console to pump cable was "fried," due to the fire, and there was black residue all over the cable.The ac adapter was replaced, the ngen console to pump cable was replaced, and the saline drip was moved away from the power cables.The procedure continued.The ngen components have been removed from use at this time.Additional information was received on 19-dec-2023.There was a fire in the lab.The fire flared up after the first application, originating from the ngen pump's power supply, which was soaked with saline from a spilled saline bag.The procedure was finished.There was no impact on the patient.There was no issue with ngen pump and trupulse generator.Both were workable after they changed the power supply cable which was burned.The saline leaked from the bag and the liquid was on top of the power cable of ngen pump.That liquid met with an electric current and caused fire.They could not check the saline bag and tubing set because those were burned.It was thought the potential leakage sites were the connection sites between the saline bag and tubing set chamber or the tubing set itself if it was damaged.The leurs / connections between the pump/tubing/saline bag fit correctly.It was not actively leaking after they extinguished the fire.Does not know if it was leaking when the incident happened.However, could confirm after the incident was the fire came from the ac adaptor of ngen pump and it was wet with saline.They could continue the procedure after they changed the ac adaptor, tubing, and the saline bag.They confirmed every connection and no leakage before they resumed the procedure.The hospital safety manager took the damaged cable.Additional information was received 22-dec-2023.No damage/issue/failure on the carto 3 system due to the fire.No sign of visible fire or flame.No excessive amount of heat during use.No part of the equipment melting/carbonized.There was a spark near the ngen pump but not near the carto 3 system.Biomed took the ngen cables and wants the ngen pump looked at.There may be damage to the ngen pump power adapter since the spark was in the same outlet it was plugged into.Additional information was received on 05-feb-2024 stating the tubing set was the ngen pump tubing.However, does not have the specific tubing product information.States, it was probably a biosense webster, inc.Product and would verify.Additional information was received on 06-feb-2024.Room was cleaned.Unsure if the equipment was cleaned prior to use or what solution it was cleaned with.There was no residue solution of isopropyl alcohol or other flammable solution in the area.They observed the fire about 30 minutes in, at first application of energy.Saline solution was in the iv bag.The trupulse remote sits in the white tray that was reflecting in the picture prior to the fire.

Manufacturer Narrative

Additional information received indicates that the device is not available for return, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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.Therefore, biosense webster manufacturer's reference number (b)(4) has two reports: (1) mfr # 2029046-2024-00191 for product code d139702 (ngen pump).(2) mfr # 2029046-2024-00681 for product code unk_smartablate pump tubing (smartablate¿ irrigation tubing set).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: SMARTABLATE¿ IRRIGATION TUBING SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): LAKE REGION MEDICAL; 31-c butterfield trail; el paso TX 79906 0000
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18810196
• MDR Text Key: 336631161
• Report Number: 2029046-2024-00681
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_SMARTABLATE PUMP TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM; NGEN PUMP, US CONFIGURATION; NGEN RF GENERATOR, US; TRUPULSE GENERATOR, US