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

Catalog Number D134805

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 12/20/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia - left (l-idvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter for which biosense webster¿s product analysis lab (pal) identified the pebax area had a hole.Initially it was reported that the carto 3 system was displaying a force sensor error 95 mid-case.They tried re-zeroing several times without resolution.They checked the fluoroscopy machine but the issue persisted.The cable and catheter were reseated but the issue persisted.They checked if the catheter was in the sheath but the issue persisted.The catheter was replaced and the issue was resolved.The procedure was continued.There was no patient consequence reported.Fda user facility medwatch (b)(4) dated 30-jan-2024 was received.The ablation catheter stopped working and displayed a hi force error.The catheter was removed and replace with no harm to the patient.Clinical site notified mfg rep directly.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 09-feb-2024, observed that the pebax area had a hole and reddish material.The event/additional information received was originally considered non-reportable, however, bwi became aware of the pebax area had a hole on 09-feb-2024 and have assessed this returned condition as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation 18-jan-2024.The device evaluation was completed on 09-feb-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and screening test of the returned device were performed following bwi procedures.Visual analysis revealed that the pebax area had a hole and reddish material was observed as well.No other damage was observed.The device was connected to carto 3 system, and the device was recognized and visualized; however, error 106 appeared on the system due to an open circuit in the tip area.A manufacturing record evaluation was performed for the finished device, and no internal actions related to the reported complaint condition were identified.The issue reported by the customer was confirmed.This could be related to the sensor and the reddish material observed.It should be noted that product failure is multifactorial.The instructions for use (ifu) contain the following recommendations: the force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.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: open circuit (c0205) / investigation conclusions: cause not established (d15) / component code: sensor (b)(6) were selected as related to the customer¿s reported ¿force error¿ issue.In addition, biosense webster inc.Analysis finding of the ¿open circuit in the tip area¿.Investigation findings: material and/or chemical problem identified (c06) / investigation conclusions: unintended use error caused or contributed to event (d1102) / component code: sleeve (b)(6) were selected as related to the customer¿s reported ¿force error¿ issue.In addition, biosense webster inc.Analysis finding ¿pebax area had a hole and reddish material¿.Manufacturer¿s reference number: (b)(4).

• 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: 18848742
• MDR Text Key: 337807146
• Report Number: 2029046-2024-00749
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/06/2024

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: D134805
• Device Lot Number: 31170698L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2024
• Initial Date FDA Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2023
• 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: UNK CABLE; UNK SHEATH; UNK_CARTO 3