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

Catalog Number SAT001

Device Problem Material Integrity Problem (2978)

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

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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 an atrial fibrillation (afib) procedure with a smartablate¿ irrigation tubing set and there was a small hole in the lumen during the procedure.During the procedure, there was a small hole in the lumen of the tubing causing a leakage.To troubleshoot, the smartablate¿ irrigation tubing set was replaced.The issue was resolved.The procedure was continued.There was no patient consequence reported.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 08-feb-2024.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) during an internal review on 02-feb-2024, updated the manufactured site information.Therefore, updated the g.All manufacturers section.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a smartablate¿ irrigation tubing set.During the procedure, there was a small hole in the lumen of the tubing causing a leakage.To troubleshoot, the smartablate¿ irrigation tubing set was replaced.The issue was resolved.The procedure was continued.There was no patient consequence reported.The device evaluation was completed on 29-feb-2024.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 no damage or anomalies on the device.Customer refer that there was a small hole in the lumen of the tubing, but during the analysis in the lab, an irrigation testing was performed and no issues were observed.The device was flushing correctly, no obstruction or hole were observed.No irrigation issues were observed.A device history review was performed and no internal actions related to the complaint were found during the review.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.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).

• 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): HARMAC MEDICAL PRODUCTS; maquiladoras no. 320-a; colonia ciudad industrial; tijuana TX 79906 0000
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18592218
• MDR Text Key: 334727654
• Report Number: 2029046-2024-00310
• 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: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2024
• 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: 3008848
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2023
• 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