MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV ST; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 87069

Device Problem Temperature Problem (3022)

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

Event Date 04/22/2022

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during a supraventricular tachycardia ablation to treat atrial tachycardia an intellanav st had poor temperature control.While attempting to burn in the coronary sinus, after noticing power delivery of 1 w the temperature limit was increased from 40 to 45 degrees.Power delivery got up to 6 w and the catheter was moved to a new location but temperature reading was still 38 degrees and this power was minimally delivered.When moving to the middle of the right atrium, temperature still didn't change and there was no fluctuation while moving it.The catheter was replaced to solve the issue and the procedure was successfully completed with no patient complications.Device is expected to be returned.

Event Description

It was reported that during a supraventricular tachycardia ablation to treat atrial tachycardia an intellanav st had poor temperature control.While attempting to burn in the coronary sinus, after noticing power delivery of 1 w the temperature limit was increased from 40 to 45 degrees.Power delivery got up to 6 w and the catheter was moved to a new location but temperature reading was still 38 degrees and this power was minimally delivered.When moving to the middle of the right atrium, temperature still didn't change and there was no fluctuation while moving it.The catheter was replaced to solve the issue and the procedure was successfully completed with no patient complications.Device has been returned.

Manufacturer Narrative

The device was returned to boston scientific for analysis.Per visual inspection device does not have visual defects.Functional test revealed that the steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.The continuity test was performed and the device was found within specifications.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.

• Brand Name: INTELLANAV ST
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14381059
• MDR Text Key: 291595152
• Report Number: 2134265-2022-05497
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729963950
• UDI-Public: 08714729963950
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0026590854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Sex: Male