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

Model Number SAT001

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

E 1.Initial reporter phone : (b)(6).The biosense webster, inc.Product analysis lab received the device on (b)(6)2023.The device evaluation was completed on (b)(6)2023.Visual inspection, and a fourier transform infrared spectroscopy ftir analysis of the returned device were performed following bwi procedures.Visual analysis revealed an unknown brown material was observed in the spike tip.Due to the observed condition, an ftir analysis was required to analyze the unknown material.The analysis revealed that foreign material located in the spike is primarily composed of an aromatic hydrocarbon resin.The issue reported by the customer was confirmed.However, the root cause of the condition could be related to the handling since in the process, there are control inspection points to avoid these issues.Product failure is multifactorial.A device history record evaluation was performed for device lot ac7497876, and no internal action related to the complaint was found during the review.Biosense webster's quality process ensures all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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.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 the biosense webster inc, (bwi) product analysis lab observed an unknown brown material in the spike tip.Initially, it was reported that when the tubing set was opened, there was a brown stain on the spike tip and similar stain on the upper part of the chamber.The material was observed outside the tubing.It was not loose nor embedded.The material was adhered to the tubing plastic material.The tubing set was replaced with another new tubing set.The procedure was completed without patient consequence.The tubing set - foreign material outside tubing was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.This event is being reported because the biosense webster inc, (bwi) product analysis lab received the device for evaluation and found on (b)(6)2023 that an unknown brown material was observed in the spike tip.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6)2023.

• 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: 17187881
• MDR Text Key: 317766192
• Report Number: 2029046-2023-01366
• 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
• Report Date: 06/22/2023

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: 08/31/2023
• Device Model Number: SAT001
• Device Catalogue Number: SAT001
• Device Lot Number: AC7497876
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2023
• Initial Date Manufacturer Received: 05/25/2023
• Initial Date FDA Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2022
• 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