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 09/03/2021

Event Type  malfunction  

Manufacturer Narrative

If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and a foreign material was found.It was reported that there was a film and foreign material inside the tubing.Tubing was not used on the patient.Replacement tubing of a different lot was used for the procedure.Unsure of what the substance was on the tubing.The substance was found on the inside of tubing, however, was unable to determine if the substance was attached or floating.There was no patient consequence.The issue film on the tubing is not considered to be a reportable malfunction since this is a material cosmetic topic and not actually a film that can be detached from the inner wall and therefore cause any risk to the patient.A possibly free floating foreign material substance is considered to be an mdr reportable malfunction.

Manufacturer Narrative

On 15-oct-2021, 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).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a smartablate¿ irrigation tubing set and a foreign material was found.It was reported that there was a film and foreign material inside the tubing.Tubing was not used on the patient.Replacement tubing of a different lot was used for the procedure.Unsure of what the substance was on the tubing.The substance was found on the inside of tubing, however, was unable to determine if the substance was attached or floating.There was no patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation and the evaluation has been completed.Bwi conducted a visual inspection and irrigation test of the returned device.Visual analysis of the returned sample revealed that the inner diameter of the smartablate¿ irrigation tubing set was found cloudy.No foreign material was observed, the reported foreign material could be the film causing the cloudy tubing.Irrigation testing was performed, following bwi procedures.No issues were observed.All devices are manufactured, inspected, and released to approved specifications as part of bwi's quality process.Cloudiness on the smart ablate tubing has been investigated by a cross-functional team and the engineering analysis suggests that a plasticizer migration in the tubing product may 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).The event described was confirmed since device was found cloudy.An internal corrective action was opened to introduce optimization actions regarding cloudiness and microbubbles.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the foreign material issue reported.No foreign material was found.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: known inherent risk of device (d12) / component code: device ingredient or reagent (g01003) related to the cloudiness found in the material during evaluation.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)per internal review on 8-jun-2022, the manufacturing site name and address have been updated to reflect lake region medical.All the appropriate fields in section g.All manufacturers have been updated accordingly.

• 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 91706
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12530658
• MDR Text Key: 273300679
• Report Number: 2029046-2021-01620
• 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,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6380116
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2021
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2021
• 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: SMARTABLATE IRR TUBE SET.