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

Catalog Number D134702

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Transient Ischemic Attack (2109)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

Manufacturer's ref.No: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter and suffered a transient ischemic attack.During the procedure, impedance rises were noted during the ablation.The catheter was removed from patient¿s body and char was observed attached to the tip of the catheter.The char was removed, and the catheter was put back into the body.Once the char was visually cleared, there did not appear to be any flow related issues.Temperature related issues were not apparent outside of this physician¿s usual workflow.Char reoccurred later in the case.The generator was used in temperature-control at 30 watts on the posterior wall of the left atrium.The temperature cut-off was set at 65 degrees.The parameters observed during the case included temperature over 30 degrees and impedance around 120 ohms.The flow rates were used according to the instructions for use.Anticoagulant (heparin boluses) were administered to the patient to achieve target activated clotting time (act) while monitoring acts every 15 minutes.No error messages were observed on any biosense webster, inc.Equipment during the procedure.No patient consequences reported.The char was assessed as not reportable.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.Additional information was received on january 9, 2019, that few days after the case, the patient suffered a small stroke.There is no information about the hospitalization and if any intervention was performed.The physician was uncertain of the cause of the event.He stated it may not be related to the char that was found on the catheter.The patient is expected to make a full recovery.No further information is available.The additional information provided on january 9, 2019 stating that patient suffered a ¿transient ischemic attack¿ was assessed as serious and reportable.Therefore, the awareness date for this reportable patient event was january 9, 2019.

Manufacturer Narrative

The manufacturing record evaluation, manufactured date and expiration date have been provided on january 31, 2019.Therefore, manufactured date fields have been populated.A manufacturing record evaluation was performed for the finished device 30121483l number, and no internal action related to the reported complaint condition were identified.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Manufacturer¿s reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8282097
• MDR Text Key: 134235103
• Report Number: 2029046-2019-02607
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/10/2019
• Device Catalogue Number: D134702
• Device Lot Number: 30121483L
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 01/31/2019
• Supplement Dates FDA Received: 02/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other