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

Model Number SAT001

Device Problem Material Integrity Problem (2978)

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

Event Date 02/02/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a smartablate¿ irrigation tubing set and a tubing damage occurred during the procedure.It was reported that during the operation, the smartablate¿ irrigation tubing set was found damaged.A second device was used to complete the operation.There was no adverse event reported on patient.

Manufacturer Narrative

This report is being submitted pursuant to the provisions of 21 cfr, part 803.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.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 ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a smartablate¿ irrigation tubing set and a tubing damage occurred during the procedure.It was reported that during the operation, the smartablate¿ irrigation tubing set was found damaged.A second device was used to complete the operation.There was no adverse event reported on patient.Device investigation details: the device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation performed for the finished device with lot number ac7350714 identified no internal actions related to the reported complaint condition.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) on 23-jun-2023, it was noticed the incorrect manufacturer's ref.# was reported in section h10.Of the 3500a supplemental (follow-up) 1.The incorrect reference # was "(b)(4)".The correct reference # is "(b)(4)".

Manufacturer Narrative

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a smartablate¿ irrigation tubing set and a tubing damage occurred during the procedure.It was reported that during the operation, the smartablate¿ irrigation tubing set was found damaged.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection and irrigation test of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned sample revealed that the inner diameter of the device was cloudy; no other damage or anomalies were observed.Irrigation testing was performed and no bubbles were observed.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 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) and the smartablate irrigation tubing set preparation workflow.Corrective and preventive actions (capa) are being followed to introduce optimization actions on devices with cloudiness and microbubbles.A device history record was performed for the finished device batch number, and no internal actions were identified.Since cloudiness was observed, this failure could be related to the issue reported by the customer; therefore, the customer complaint was confirmed.Bubbles reported may be related to a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of smartablate pump.As part of the quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

On 26-jan-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (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: 16457957
• MDR Text Key: 310415775
• Report Number: 2029046-2023-00412
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009743
• UDI-Public: 10846835009743
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P990017/S17
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC7350714
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/02/2023
• Initial Date FDA Received: 03/01/2023
• Supplement Dates Manufacturer Received: 06/01/2023; 06/23/2023; 01/26/2024; 02/02/2024
• Supplement Dates FDA Received: 06/24/2023; 06/27/2023; 01/28/2024; 02/27/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2022
• 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
• Treatment: SMARTABLATE IRR TUBE SET