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

Model Number D134805

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 11/10/2022

Event Type  malfunction  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 12-dec-2022.The device evaluation was completed on 27-dec-2022.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and functional tests were performed following bwi procedures.Visual analysis revealed that there was a hole in the pebax.Reddish material inside the pebax was also observed.No char was observed during the inspection or the decontamination process.The damage could be related to excessive force or manipulation, but this cannot be conclusively determined.The root cause of the hole remains unknown.The temperature and impedance test was performed and the device was found to be working correctly.No temperature or impedance issues were observed.Also, a cool flow pump and pressure gage was performed: no irrigation issues were observed.A manufacturing record evaluation was performed for the finished device batch number, and internal actions were identified.The issue reported by the customer could not be replicated during the investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.Char is a physical phenomenon of radio-frequency; it can be the usual result of the ablation process; however, the instructions for use contain the following instruction: monitoring the temperature from the electrode during the application of rf current ensures that the irrigation flow rate is being maintained.Using tip temperature to guide ablation could result in deeper lesions and an increased risk for collateral damage.As part of bwi¿s quality process, all devices are manufactured, inspected, and released to approved specifications explanation of codes: manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the biosense webster product analysis lab observed a hole in the pebax.During the procedure, as the catheter was being removed from the patient, the physician saw a lot of blood stuck to the tip of the catheter.They confirmed the catheter had been "heparinized and flushed appropriately".To troubleshoot, the physician tried scraping the catheter tip to get the blood off without resolution.He then replaced the catheter and the issue was resolved.There was no patient consequence reported.Additional information was received.Sheath used was an 8.5fr sl1 sheath.There were no issues with maneuverability or withdrawal and no injury to the patient.They did not see any physical damage to the catheter.They have no pictures to provide but the catheter is being returned.The event was assessed as not mdr reportable for char.Char is a physical phenomenon of radio frequency 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 biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 27-dec-2022 there was a hole in the pebax.Reddish material inside the pebax was also observed.The hole in the pebax was assessed as mdr reportable.The awareness date for this reportable lab finding was 27-dec-2022.

• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16218710
• MDR Text Key: 309082167
• Report Number: 2029046-2023-00138
• 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: 01/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30897952L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2022
• Date Manufacturer Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2022
• 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: CARTO 3 SYSTEM; NON BWI-8.5FR SL1 SHEATH; UNKNOWN BRAND CATHETER