MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D132705

Device Problems Complete Blockage (1094); Contamination /Decontamination Problem (2895)

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

Event Date 03/19/2024

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) ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and a plastic piece blocking the lumen was observed.It was reported that the irrigation lumen on smart touch catheter was blocked.They tried flushing the catheter, but it was not flushing.There was very low flow exiting the open tip of the catheter.They tried to open the lumen using a thin wire, but it would not enter.The scrub nurse noticed a plastic piece blocking the lumen.They tried to remove it with a needle, but the flow issue did not resolve.The catheter was not inserted into the patient's body.They noticed the issue early on and changed the catheter.The catheter was replaced, as they were about to cross to the left side of the heart and having inadequate flow is a safety issue, especially when ablating.The new catheter flushed normally and there were no issues observed afterwards.The procedure was successfully completed.No adverse patient consequence was reported.Additional information was received which confirmed that the issue was noted before the item was used on the patient.Consequently, the item was not used on the patient.No error was noted on the pump.The issue was identified seeing a low flow exiting the catheter tip while the smartablate pump was on high flow (>100 ml/min) to flush the catheter.Also, they noticed the fluid was being backed up in the tubing before reaching the catheter.Correct catheter settings were selected on device.According to the scrub nurse, he was able to move this foreign material using a needle, and therefore it was described as loose (with movement).The foreign material was a white, oval shaped, paper-thin plastic-like material with a 2-3 mm diameter.The pebax did not look physically damaged.It will be shipped with the catheter for further examination.

Manufacturer Narrative

The device investigation has been completed which included performing a manufacturing record evaluation (mre).The manufacturing record evaluation was performed for the finished device number lot 31096366m, and no internal action related to the complaint was found during the review.Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19106600
• MDR Text Key: 340240470
• Report Number: 2029046-2024-01228
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: TC
• PMA/PMN Number: P030031/S053
• 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
• Report Date: 05/17/2024

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 Catalogue Number: D132705
• Device Lot Number: 31096366M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/15/2024
• Supplement Dates Manufacturer Received: 04/23/2024
• Supplement Dates FDA Received: 05/17/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/30/2023
• 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
• Treatment: SMARTABLATE PUMP SPARE-WW
• Patient Age: 44 YR
• Patient Sex: Male