MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ ELECTROPHYSIOLOGY CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number D133604IL

Device Problems Insufficient Cooling (1130); Device Contamination with Body Fluid (2317); Obstruction of Flow (2423)

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

Event Date 12/24/2023

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.However, the video analysis was completed.Device investigation details: a video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, an inadequate irrigation from the device was observed, this irrigation issue may be related to the high temperature issue reported; however, the char issue described by the customer could not be confirmed based on this evidence.A manufacturing record evaluation was performed for finished device number (b)(6), and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed based on the video received.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the medical team found that there was char and inadequate irrigation.The char, a solid carbonized material, was formed close to or on electrode(s) of catheter during ablation procedure.The patient was anticoagulated.There was also an intermittent or low irrigation on the device but not complete occlusion.While flushing, blocked holes were identified.The temperature cut-off was exceeded and the system stopped ablation.A second device was used to complete the operation.There was no adverse event reported on patient.

Manufacturer Narrative

On (b)(6) 2024, the bwi product analysis lab received the device for evaluation.The product investigation was subsequently completed.It was reported that a patient underwent an atrial fibrillation (afib) - paroxysmal ablation procedure with a thermocool® smart touch¿ electrophysiology catheter and the medical team found that there was char and inadequate irrigation.The char, a solid carbonized material, was formed close to or on electrode(s) of catheter during ablation procedure.The patient was anticoagulated.There was also an intermittent or low irrigation on the device but not complete occlusion.While flushing, blocked holes were identified.The temperature cut-off was exceeded and the system stopped ablation.A second device was used to complete the operation.There was no adverse event reported on patient.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection, flow pump, and temperature and impedance tests of the returned device were performed in accordance with bwi procedures.Visual analysis of the returned device revealed that no damage or anomalies were observed on the device, however, char attached to the tip of the device was observed.Temperature and irrigation test were performed and no issues were observed.A manufacturing record evaluation was performed for the finished device 31146485m, and no internal action was found during the review.The issues reported by the customer were confirmed.It should be noted that product failure is multifactorial.The evaluation determined that char is a physical phenomenon of rf (radiofrequency), and it can be the normal result of the ablation process.The instructions for use contain the following guideline: 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 increased risk for collateral damage.Despite the results of the tests, it was determined that the char issue may be related to the event described by the customer; however, this could not be conclusively determined.As part of biosense webster's quality process, all devices are manufactured, inspected, and released 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¿ ELECTROPHYSIOLOGY 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: 18548342
• MDR Text Key: 333512058
• Report Number: 2029046-2024-00254
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D133604IL
• Device Lot Number: 31146485M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/19/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM WITH VISITAG.; UNKNOWN IRRIGATION PUMP.; UNKNOWN RF GENERATOR.