MAUDE Adverse Event Report: BIOSENSE WEBSTER INC SMARTABLATE IRR TUBE SET; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number SAT001

Device Problems Material Opacification (1426); Contamination /Decontamination Problem (2895); Air/Gas in Device (4062)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

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 a patient underwent cardiac ablation procedure with a smartablate¿ irrigation tubing set where foreign material inside tubing occurred.It was reported by the caller the smartablate¿ irrigation tubing set seemed to have a crystal residue in the tubing and when flushed microbubbles are formed and they are not able to be cleared.The caller stated that when the tubing is opened there appears to be a dry residue inside the tubing.They exchanged the tubing twice and the issue was resolved.The material was definitely inside the tubing.The material did not move, embedded on the interior.The most observable residue, for the most apt description, looks like a dustiness or cloudiness inside the tubing.It¿s observable often without running fluid through the tubing by holding it up to the light.It doesn¿t really have a color, it¿s just slightly off from the color of the tubing itself.Running fluid through the tubing usually makes it more visible, and often catches bubbles or makes it look like there are bubbles that cannot be cleared by flushing.The set was flushed in both directions and used almost 500ml to no effect.The tubing was never used in the patient in any of the instances.The bubbles in the tubing-set is not mdr-reportable.The foreign material inside of tubing is mdr-reportable.This report is for the 2nd of 2 smartablate¿ irrigation tubing sets.The other set was reported in manufacturer report number 2029046-2020-02004.

Manufacturer Narrative

On 1/13/2021, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent cardiac ablation procedure with a smartablate¿ irrigation tubing set where foreign material inside tubing occurred.It was reported by the caller the smartablate¿ irrigation tubing set seemed to have a crystal residue in the tubing and when flushed microbubbles are formed and they are not able to be cleared.The caller stated that when the tubing is opened there appears to be a dry residue inside the tubing.They exchanged the tubing twice and the issue was resolved.Device evaluation details: during the investigation of this complaint, the customer provided a picture of the reported foreign material however, when the device was received in the lab and visual inspection was performed, the material was not found.However 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).A device history record evaluation was performed for the finished device ac5951809 number, and no internal actions related to the reported complaint condition were identified.Complaint was not able to be confirmed.The root cause of the loss of the foreign material could be related to the decontamination process or when the device was shipped for analysis for this reason the appropriate test to identify the composition of the foreign material source cannot be performed.Bubbles reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of smartablate pump.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 IRR TUBE SET
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (IRWINDALE); 15715 arrow highway; irwindale CA 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11086230
• MDR Text Key: 248905639
• Report Number: 2029046-2020-02003
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2021
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC5951809
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2020
• 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