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

Model Number SAT001

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set.There was tubing was leaking during use on the patient.There was no error code there was pump error.There was no problem in confirming the irrigation of stsf during puncture.Subsequently a transeptal puncture (bb) was performed and a pentaray and cryo catheter were inserted in the left atrium.After cryo ablation was performed for stsf, an error in the pump was confirmed at the timing when it attempted to insert thermocool® smart touch® sf bi-directional navigation catheter (stsf) intracardially to perform touch up.The error was resolved after the start of the pump again, but liquid was found at the tubing installation site.When tubing was checked, breakage and leakage of liquid from the damaged site were confirmed.This occurred about three (3) hours since the procedure was started.The tubing was changed and there was no error or issues and the procedure was ended normally.The procedure was completed without patient's consequence.No picture available.They were not ablating when pump error and leakage were noted.Tubing set leakage is mdr-reportable.Mid-procedure tubing issue is mdr-reportable.

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).

Manufacturer Narrative

On 6-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 tubing was leaking during use on the patient.Device evaluation details: visual analysis of the returned sample revealed no damage or anomalies on the device irrigation testing was performed.No issues were observed.A manufacturing record evaluation was performed for the finished device ac6501347 number, and no internal actions related to the complaint were found during the review.No issues related to the reported event were found.However, it should be considered that 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 could not be confirmed as the device performed without any issues.Bubbles reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of the 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).

Manufacturer Narrative

On 1-apr-2022, bwi received additional information regarding the event.The tubing part of the device was damaged.The medical team was not ablating when pump error and leakage were noted.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 0000
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13940120
• MDR Text Key: 290455152
• Report Number: 2029046-2022-00666
• 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: 06/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6501347
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2021
• 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
• Treatment: PENTARAY NAV CATHETER; SMARTABLATE PUMP; THERMOCOOL SMARTTOUCH; UNSPECIFIED CRYO CATHETER