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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster, inc.Product analysis lab observed and a hole on the pebax.Initially it was reported that a thermocool® smart touch® sf bi-directional navigation catheter had a current leakage error on the carto 3 system.Removed all connections from the patient interface unit and connected all until the thermocool® smart touch® sf bi-directional navigation catheter was connected and the error displayed again.The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The case continued.The issue was catheter-related.The carto 3 system was operating per specifications and was not responsible for the product issue.Additional information was received on the event.The current leakage error was seen concurrently with a loss of ecg signals on the carto 3 system and the recording system.Signal loss was observed on the body surface signals.Signals were available on the defibrillator and anesthesia.During the signal loss, the affected catheter was inside the patient¿s body.The current leakage issue was assessed as not mdr reportable.This issue was highly detectable and requires adjusting system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.The signal issue was assessed as not mdr reportable.The risk to the patient was low.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 28-jun-2022, it was found that there was reddish material on the pebax, mechanical damage and a hole on the pebax surface.The hole on the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 28-jun-2022.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 13-jun-2022.The device evaluation was completed on 28-jun-2022.The product was returned to biosense webster for evaluation.A visual inspection, magnetic sensor functionality test and electrical evaluation of the returned device were performed following bwi procedures.Visual analysis revealed reddish material on the pebax.A magnetic sensor functionality test was performed, and the device was visualized and recognized correctly; no magnetic issues were observed.An electrical test was performed, and an open circuit was found on the tip area.Additionally, a scanning electron microscope (sem) testing was performed on the pebax area and the results showed evidence of mechanical damage, and a hole on the pebax surface.Object that caused the damage is unknown.No other anomalies were observed.A manufacturing record evaluation was performed 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.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 ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15071693
• MDR Text Key: 304127548
• Report Number: 2029046-2022-01670
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/19/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30770407L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Date Manufacturer Received: 06/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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: SOUNDSTAR ECO SMS 8F CATHETER; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER; UNKNOWN BRAND RECORDING SYSTEM; UNK_CARTO 3; UNK_SOUNDSTAR ECO CABLE