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 11/20/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a smartablate¿ irrigation tubing set in which there was a mid-procedure irrigation issue.During ablation, ablation was stopped several times due to a temperature abnormality.Upon checking the pump, the tube was caught on the upper side of the rotator plate and was not flowing.Blood was flowing back toward the tube.When setting the tube, it was set as usual, and it was confirmed that the tube was flowing without any problem.The issue was resolved by setting the tubing set again.Bubbles were not confirmed at the pump.Bubble movement was absent while the pump was operating.There were no pump errors noted.The ablation never continued beyond the cut-off value.No patient consequences were noted.

Manufacturer Narrative

E1 initial reporter phone: 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 (b)(6) 2024, 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.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 1-feb-2024, the product investigation was completed.It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a smartablate¿ irrigation tubing set in which there was a mid-procedure irrigation issue.During ablation, ablation was stopped several times due to a temperature abnormality.Upon checking the pump, the tube was caught on the upper side of the rotator plate and was not flowing.Blood was flowing back toward the tube.When setting the tube, it was set as usual, and it was confirmed that the tube was flowing without any problem.The issue was resolved by setting the tubing set again.Bubbles were not confirmed at the pump.Bubble movement was absent while the pump was operating.There were no pump errors noted.The ablation never continued beyond the cut-off value.No patient consequences were noted.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 testing was performed and no issues were observed.The tubing was irrigated properly.Device history record was performed for the finished device ac8544033 number, and no internal actions related to the reported complaint condition were identified.No issues related to the reported event were found.However, it should be considered that 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.The event described could not be confirmed as the device performed without any issues.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).

• 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: 18340028
• MDR Text Key: 331050915
• Report Number: 2029046-2023-02985
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 02/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2023
• 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: AC8544033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/01/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2023
• 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 PUMP; THERMOCOOL SMARTTOUCH