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 04/13/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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) with a smartablate¿ irrigation tubing set.The inside of the tube was cloudy, and fine foreign matters were visually observed.When setting to the pump for using the af procedure, the inside of the tube was cloudy, and fine foreign matters were visually observed.At the request of the physician, the team replaced the product and performed the procedure.The procedure was completed without patient's consequence.No further information is available.The material observed was inside and did not seem to be able to be removed from the tubing.The cloudiness observed is not mdr-reportable.The foreign material observed is mdr-reportable.

Manufacturer Narrative

On 5/28/2021, 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: pc-(b)(4).

Manufacturer Narrative

On(b)(6)2021, the product investigation was completed.It was reported that an unknown patient underwent an atrial fibrillation (afib) with a smartablate¿ irrigation tubing set.The inside of the tube was cloudy, and fine foreign matters were visually observed.When setting to the pump for using the af procedure, the inside of the tube was cloudy, and fine foreign matters were visually observed.At the request of the physician, the team replaced the product and performed the procedure.The procedure was completed without patient's consequence.Device evaluation details: according to the information reported, when setting to the pump for using the af procedure, the inside of the tube was cloudy, and fine foreign matters were visually checked.The returned tubing was inspected, and no visible damage was found.Irrigation test was performed, microbubbles were found in the tubing after flushing.These bubbles did not move during analysis.Alarm was not activated.No damage or foreign material were detected.A cross-functional team has reviewed this issue and we provide the following information supporting the safety of our product.A manufacturing record evaluation was performed for the finished device ac5931909 number, and no internal actions related to the reported complaint condition were identified.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.An independent evaluation completed by an internationally accredited engineering and scientific consultancy determined that the plasticizer is not toxic and will not result in adverse health effects in cardiac ablation patients under normal use conditions.Engineering evaluation has determined that 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).Complaint was confirmed.Opacity reported is 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¿ IRRIGATION TUBING 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: 11759080
• MDR Text Key: 266681202
• Report Number: 2029046-2021-00699
• 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,Followup
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2021
• 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: AC5931909
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/12/2020
• 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