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

Catalog Number UNK_SMARTABLATE PUMP TUBING

Device Problems Obstruction of Flow (2423); Air/Gas in Device (4062)

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

Event Date 03/19/2024

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 Description

It was reported that a patient underwent an atrial fibrillation (afib) ¿ paroxysmal ablation procedure with a smartablate¿ irrigation tubing set and at the beginning of the procedure, the ngen bubble alarm went off.Upon inspection of the tubing, they discovered microbubbles.The tubing was replaced, and the issue resolved temporarily.Shortly after they noticed the surpoint numbers were "low" on the carto 3 system.The ngen generator was unable to get up to 50 watts due to the irrigation not flowing properly.The temperature was too hot which did not allow the power to get up to 50 watts.Upon inspection of the tubing, they noticed microbubbles again inside the tubing.They removed the catheter from the body, and they were able to successfully power flush the catheter.After the catheter was reinserted into the body, they were able to successfully get up to 50 watts of power and the issue resolved.Replacement tubing requested.No adverse patient consequence was reported.Additional information was received, and it was reported that it is unknown if the tubing or the pump was causing the ineffective cooling of the catheter tip.They were getting microbubbles frequently throughout the case before they had the cooling issue.To resolve the irrigation issue, they removed the ablation catheter from the body.Power flushed and ensured proper flow to the tip.They re-inserted the catheter to the body.Correct catheter settings were selected on the generator.

Manufacturer Narrative

Since no device has been received for analysis, 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.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: 19111104
• MDR Text Key: 340230936
• Report Number: 2029046-2024-01244
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• 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
• Report Date: 04/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2024
• 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
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: No
• 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: NGEN PUMP, US CONFIGURATION; SMARTABLATE IRR TUBE SET; UNK_CARTO 3; UNK_NGEN RF GENERATOR; UNK_QDOT MICRO