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

Model Number D134801

Device Problems Complete Blockage (1094); Device Contamination with Body Fluid (2317)

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

Event Date 02/06/2023

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.The device was returned to biosense webster (bwi) for evaluation.A visual inspection evaluation and cool flow pump and pressure gage test of the returned device was performed following bwi procedures.Visual analysis revealed no anomalies or damages on the device.A cool flow pump and pressure gage test was performed, and the device failed the test.Afterward, a microscopic evaluation of the dome was performed, and a transparent foreign material blocking the irrigation holes was observed.For this reason, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested, and it was found that the material observed was carboxylate-base.This failure could be related to the occlusion reported by the customer; however, this cannot be conclusively determined.A manufacturing record evaluation was performed for the finished device 30916839l number, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi¿s quality system.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 char issue.Investigation findings: inappropriate material (c0602)) / investigation conclusions: cause not established (d15) / component code: dome (g04046)) were selected as related to the foreign material observed.Investigation findings: operational problem identified (c13) / investigation conclusions: cause not established (d15) / component code: dome (g04046)) were selected as related to the occlusion / no irrigation issue.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 thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster inc, (bwi) product analysis lab observed a transparent foreign material blocking the irrigation holes.Initially, it was reported that during pulmonary vein isolation (pvi), when flashing, char was seen in the tip of the irrigation hole and no water was coming out.It occurred one hour after catheter use.The catheter was replaced, and the procedure continued.No neurological symptom occurred since the procedure was completed.No adverse patient consequence was reported.The char is not mdr reportable.Char is a physical phenomenon of radiofrequency (rf) energy delivery and can be the normal result of the ablation process.The presence of char on the electrodes does not represent a serious injury in itself, nor is it necessarily the result of device malfunction.The occlusion/no irrigation is 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 12-apr-2023 that there was a transparent foreign material blocking the irrigation holes.This finding was assessed as mdr reportable.Therefore, the awareness date for this reportable lab finding is (b)(6) 2023.

• Brand Name: THERMOCOOL® SMART TOUCH® SF 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: 16908368
• MDR Text Key: 315088209
• Report Number: 2029046-2023-00993
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031
• 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: 05/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30916839L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Date Manufacturer Received: 04/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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: JPN CARTO 3 SYSTEM.; THMCL SMTCH SF BID, TC, D-D.; UNK OPTICAL DVI CABLE.; UNK OPTICAL DVI CABLE.