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

Catalog Number SAT001

Device Problem Material Integrity Problem (2978)

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

Event Date 11/29/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unspecified cardiac ablation procedure with a smartablate¿ irrigation tubing set and there was an issue with the presence of bubbles inside the tubing.Despite several techniques for removing bubbles when purging the tubing, bubbles reappear during the ablation.The medical team did not want to risk a gas embolism.No further details were provided regarding the event or completion of the procedure.No patient consequences were reported.

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).

Manufacturer Narrative

On 29-feb-2024, the product investigation was completed.It was reported that a patient underwent an unspecified cardiac ablation procedure with a smartablate¿ irrigation tubing set and there was an issue with the presence of bubbles inside the tubing.Despite several techniques for removing bubbles when purging the tubing, bubbles reappear during the ablation.The medical team did not want to risk a gas embolism.No further details were provided regarding the event or completion of the procedure.Device evaluation details: the product was returned to biosense webster (bwi) for evaluation.A visual inspection and irrigation test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned sample revealed no damage or anomalies on the device.Irrigation test was performed and bubbles with no movement were observed during the test.Bubbles on the smart ablate tubing have been investigated by a cross functional team and the engineering analysis suggests that a plasticizer migration in the tubing product may be contribute to a change in tubing appearance including opacity, increase in lumen roughness as well as microbubble adhesion.Plasticizer migration is a known phenomenon in softer polyvinyl chloride (pvc) materials like our tubing set.Additionally, an independent evaluation determined that the plasticizer is not toxic and will not result in adverse health effects in cardiac ablation patients under normal use conditions.Despite any change in tubing appearance, bubbles in the saline remain readily detectable.In addition, the bubble sensor on the smartablate pump uses ultrasound signals and the sensitivity of this sensor is unaffected by any change in tubing appearance.Customers should continue to properly prime and flush tubing per the instructions for use (ifu) and the smartablate irrigation tubing set preparation workflow.Device history record was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.The event described by the customer was confirmed.Bubbles reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of smartablate pump.As part of the 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).

Manufacturer Narrative

On 16-apr-2024, bwi received additional information indicating that the microbubbles did not present a patient risk.The presence of microbubbles that were reportedly unable to be flushed.This issue is related to the presence of actual air bubbles within the lumen of the tubing.If air bubbles cannot be flushed then it is not a safety issue as the user will not use the tubing.Any microbubbles of sufficient size would also be detected by the generator via its bubble detector.No issues on the pump were reported as the pump was able to detect the bubbles as intended.In addition, the issue occurred during flushing.As a result, this event is not mdr-reportable.No further details will be submitted for this event.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

On 6-feb-2025, bwi received additional information regarding the event.The issue occurred during flushing.The tubing with bubbles had been connected to devices while inside the patient.The device was connected to a saline bag and passed through the pump.Bubbles were identified throughout the entire length of the tubing.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: 18477437
• MDR Text Key: 332456947
• Report Number: 2029046-2024-00113
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/17/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAT001
• Device Lot Number: AC8544034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/07/2023
• 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: SMARTABLATE GENERATOR; SMARTABLATE PUMP