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 03/16/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a smartablate¿ irrigation tubing set and a foreign matter inside the tubing issue occurred.It was reported that a small foreign matter was found in the tip of the tube.According to the physician's assessment, it is not a bubble, so it is not clear whether it is a coating material for the tube or whether it contains precipitate.The event was discovered before it was inserted into the cardiac cavity when flushing.The device was not used on the patient.The material observed was inside the tubing.The material observed inside the tubing had no movement.Because the foreign matter remained even with a flush, it was judged to be a precipitate.The procedure was completed with a new tubing.Bubble movement during pump operation was unknown and there were no error messages.The procedure was completed without patient consequence.This issue was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Manufacturer's reference number: pc-001090757 during an internal review on (b)(6)-2022, it was noted that the manufacturing record evaluation (mre) was inadvertently excluded from 3500a follow up report #mwr-06062022-0001196678.A manufacturing record evaluation (mre) was performed for the finished device ac6551721 number, and no internal action related to the complaint were found during the review.

Manufacturer Narrative

The device evaluation was completed on 06-jun-2022.It was reported that a patient underwent a cardiac ablation procedure with a smartablate¿ irrigation tubing set and a foreign matter inside the tubing issue occurred.It was reported that a small foreign matter was found in the tip of the tube.According to the physician's assessment, it is not a bubble, so it is not clear whether it is a coating material for the tube or whether it contains precipitate.The event was discovered before it was inserted into the cardiac cavity when flushing.The device was not used on the patient.The material observed was inside the tubing.The material observed inside the tubing had no movement.Because the foreign matter remained even with a flush, it was judged to be a precipitate.The procedure was completed with a new tubing.Bubble movement during pump operation was unknown and there were no error messages.The procedure was completed without patient consequence.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and irrigation test of the returned device.Visual analysis of the returned sample revealed that the inner diameter was found cloudy.No foreign matter was found inside the tube and picture received by the customer does not provide sufficient information related to the reported event and therefore no result can be obtained from it.However, cloudy issue was found unrelated.Irrigation testing was performed, in accordance with bwi procedures.No issues were observed.Cloudiness on the smartablate tubing has been investigated by a cross-functional team and the engineering analysis suggests that a plasticizer migration in the tubing product might contribute to a change in tubing appearance including opacity, and 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).An internal corrective action has been opened to further investigate the issue.The event described was not confirmed.Cloudiness was found unrelated and may be associated with a known plasticizer migration phenomenon of pvc materials and has no interference with the functionality of the smartablate pump.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: no problem detected (d14) were selected as related to the customer¿s reported foreign matter inside the tubing.Investigation findings: material and/or chemical problem identified (c06)/ investigation conclusions: known inherent risk of device (d12)/ component code: device ingredient or reagent (g01003) were selected as related to the material related issue.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

The biosense webster, inc.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).

Manufacturer Narrative

After additional review on 23-aug-2022, it has been determined that the material that was initially reported as a foreign matter inside the tubing is a cloudy/film precipitate and is not considered a foreign matter.Therefore, the h 6.Medical device problem code has been updated.This event will no longer be considered as mdr reportable against any biosense webster inc.Devices.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 0000
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14106157
• MDR Text Key: 289753138
• Report Number: 2029046-2022-00799
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2022
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC6551721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/05/2021
• 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: UNK TUBING SET