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

Catalog Number SAT001

Device Problems Complete Blockage (1094); Material Opacification (1426)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure which included a smartablate¿ irrigation tubing set and it was observed that the tubing was cloudy and not allowing bubbles to be seen and ¿impossible to purge tubing¿.Additional information was received, and it was reported that the issue occurred during flushing.The tubing was connected to the pump.The tubing was flushed before using in the patient and the bubbles were detected after passing through the pump sensor.The issue with the tubing set not irrigating was due to a reported foreign material.With the information available, this event was assessed as mdr reportable.

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).

Manufacturer Narrative

The biosense webster, inc.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

The device evaluation was completed on 10-nov-2023.It was reported that a patient underwent a cardiac ablation procedure which included a smartablate¿ irrigation tubing set and it was observed that the tubing was cloudy and not allowing bubbles to be seen and ¿impossible to purge tubing¿.Additional information was received, and it was reported that the issue occurred during flushing.The tubing was connected to the pump.The tubing was flushed before using in the patient and the bubbles were detected after passing through the pump sensor.The issue with the tubing set not irrigating was due to a reported foreign material.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 that the inner diameter of the device was cloudy.No other damage or anomalies were observed besides the cloudiness.Irrigation testing was performed and no bubbles or occlusions were observed.Device history record was performed for the finished device ac8302843 number, and no internal action related to the complaint was found during the review.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.Cloudiness 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 have contributed 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.An internal corrective action is being followed to reduce these issues.The cloudy condition reported by the customer was confirmed.Cloudiness reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of smartablate pump.The occlusion reported could not be confirmed during the product investigation.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: known inherent risk of device (d12) / component code: device ingredient or reagent (g01003) were selected as related to the customer¿s reported cloudy tubing.Investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14 ) were selected as related to the customer¿s reported tubing set not irrigating due to a foreign material.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(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: 17810174
• MDR Text Key: 324171190
• Report Number: 2029046-2023-02163
• 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
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2024
• Device Catalogue Number: SAT001
• Device Lot Number: AC8302843
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2023
• 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