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

Catalog Number SAT001

Device Problems Tear, Rip or Hole in Device Packaging (2385); Manufacturing, Packaging or Shipping Problem (2975); Material Integrity Problem (2978)

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

Event Date 09/14/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).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.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 an unspecified ablation procedure with a smartablate¿ irrigation tubing set and prior to use the medical team identified an out of box failure: the pouch seal was already opened.During the procedure, scratches were also identified on the surface of the tubing set.The damage was identified while priming the tubing after pump connection.Bubbles were also identified above the pump upstream.The issue was resolved by replacing the tubing set to another new one.The procedure then proceeded without delay and it was completed without any problems.The bubbles are not mdr-reportable.The scratches are not mdr-reportable.The opened pouch seal is mdr-reportable.

Manufacturer Narrative

On 22-nov-2023, the product investigation was completed.It was reported that a patient underwent an unspecified ablation procedure with a smartablate¿ irrigation tubing set and prior to use the medical team identified an out of box failure: the pouch seal was already opened.During the procedure, scratches were also identified on the surface of the tubing set.The damage was identified while priming the tubing after pump connection.Bubbles were also identified above the pump upstream.The issue was resolved by replacing the tubing set to another new one.The procedure then proceeded without delay and it was completed without any problems.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.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 test was performed and bubbles with no movement were observed during the test.The scratches on the surface of the tubing reported by the customer could be related with the cloudiness and bubbles identify during the analysis, however, this can not be conclusively determined.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).Due to the condition of the tubing, an internal action was opened.A device history review was performed for the finished device ac8452106 number, and no internal actions related to the complaint were found during the review.The out of box failure and open pouch seal issue were unable to analyze since the pouch and the seal do not returned for analysis, however, the tubing problems and the bubbles issue described by the customer were confirmed.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.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 reference number: (b)(4).

Manufacturer Narrative

On 25-oct-2023, 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: (b)(4) within the initial report, the expiration date was mistakenly indicated as 31-may-2024.The expiration date was updated on this form (in d4) as 30-may-2025.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17918186
• MDR Text Key: 325466561
• Report Number: 2029046-2023-02298
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SAT001
• Device Lot Number: AC8452106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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