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

Model Number SAT001

Device Problems Contamination /Decontamination Problem (2895); Air/Gas in Device (4062)

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

Event Date 03/31/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set.There was material in the tubing.When priming the irrigation tubing they were unable to removed air bubbles.This occurred after the patient entered, puncture occurred during preparation for the ablation procedure.Although, air bubbles were removed there were many remaining materials in the tube, and as there was concern about ensuring safety, the tube was replaced.The procedure was completed without patient's consequence.This event will be reportable for tubing set foreign material inside tubing based on this information.The bwi company representative confirmed that air bubbles were removed and there were many remaining materials in the tube, and as there was concern about ensuring safety.The remaining material observed in the tubing was loose (with movement) and embedded to the tubing plastic material (with no movement).Bubbles in tubing is not mdr-reportable.Foreign material inside tubing set is mdr-reportable.

Manufacturer Narrative

On 30-may-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).

Manufacturer Narrative

On 28-jun-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 material in the tubing.Device evaluation details: visual analysis of the returned sample revealed that no damage or anomalies were observed.Then, the irrigation testing was performed, in accordance with bwi procedures.Cloudiness and bubbles were observed during the irrigation test.However, foreign material was not observed in the tubing.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.Customers should continue to properly prime and flush tubing per the instructions for use (ifu).The event described was confirmed since cloudiness and bubbles were observed during the irrigation test.Cloudiness and bubbles observed during the irrigation test may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of the smartablate pump.Due to the cloudiness and microbubbles, an internal action was opened.A device history record was performed for the finished device ac6551721 number, 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).

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14219311
• MDR Text Key: 290173203
• Report Number: 2029046-2022-00879
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6551721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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