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

Model Number SAT001

Device Problems Material Opacification (1426); Contamination /Decontamination Problem (2895)

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

Event Date 10/03/2022

Event Type  malfunction  

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set.There was foreign material inside the tubing.It was reported that when the irrigation tubing was being flushed, there were a lot of bubbles discovered in the irrigation tubing.Some of the bubbles appeared to move throughout the irrigation tubing and that some would get stuck.They replaced the irrigation tubing and the irrigation tubing appeared to be discolored and have a yellowish tint to it.They replaced the irrigation tubing again and the procedure continued.No patient consequences were reported.The material observed was inside the tubing.The material observed in the tubing was loose (with movement).The issue was noticed before use on the patient.Small bubbles that could not be cleared from the fluid inside the tubing.Yellowish discoloration of the tubing set and fluid inside the tubing.Foreign material inside tubing is mdr-reportable.Bubbles in tubing is not mdr-reportable.

Manufacturer Narrative

On 2-dec-2022, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set.There was foreign material inside the tubing.Device evaluation details: visual analysis of the returned sample revealed no damage on the smartablate irr tube set.Irrigation testing was performed, and the device passed the test in accordance with bwi procedures.Opacity was observed during the irrigation test.The foreign material (i.E.Yellowish tint) reported by the customer was not observed during the test.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Cloudiness and 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 contributing 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.Due to the identified cloudiness and microbubbles, an internal action was opened.A device history record evaluation was performed for finished device number ac7276612, and no internal actions related to the complaint were found during the review.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 7-nov-2022, 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).

• 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
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15656941
• MDR Text Key: 306788164
• Report Number: 2029046-2022-02618
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC7276612
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2022
• 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