MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NR7TCSIY

Device Problems Partial Blockage (1065); Device Contamination with Body Fluid (2317)

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

Event Date 02/17/2021

Event Type  malfunction  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: pc-(b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a navistar® rmt thermocool® electrophysiology catheter and a clot issue occurred.During the procedure, the smartablate pump showed ¿bubble error¿ without visible bubbles inside the smartablate¿ irrigation tubing set.It was also reported that two irrigation holes of the navistar® rmt thermocool® electrophysiology catheter were clogged.The clogged holes could be reopened by flushing.Additional information was received on 3/2/2021.It was reported that clot was found on the tip of the catheter which could be removed by flushing the ablation duration was not greater than 60 seconds.The irrigation was set at 17-30ml/min.Normal heparinized saline was used as irrigation fluid.Time was used as coloring option.The generator parameters were: power mode, temp cut off 45 c, power 40 w.It is unknown if the patient exhibited any neurological symptoms.No adverse patient consequences were reported.The clot issue was assessed as mdr reportable under the navistar® rmt thermocool® electrophysiology catheter.The awareness date is 3/2/2021.The bubble error, as well as the irrigation inadequate issue, were assessed as not mdr reportable.

• Brand Name: NAVISTAR RMT THERMOCOOL ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 11593052
• MDR Text Key: 266105173
• Report Number: 2029046-2021-00446
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835008500
• UDI-Public: 10846835008500
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR7TCSIY
• Device Catalogue Number: NR7TCSIY
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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