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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Model Number M004ERFSDS96200
Device Problems Obstruction of Flow (2423); Connection Problem (2900)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2021
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
During an ablation procedure an intellanav stablepoint open-irrigated catheter was selected for use.It was reported that the catheter was connected to the maestro generator, however, the generator was unable to recognize the catheter.The generator was reset and the catheter was reconnected.The error persisted.The catheter was then connected to the osypka generator.Flushing difficult was observed as the pump noticed an occlusion in the system.The catheter was exchanged and the procedure was completed with no patient complications.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.No visual were noted.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.While manipulating the shaft, continuity checks revealed an electrical open in the ablation thermocouple.The device's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst (tb) seal for sealing the irrigation holes and mini electrodes (me), the lumen pressure decay was measured three times, with re-seating of the tb seal between each test.Lumen pressure decay values were all below the maximum acceptable limit.The device was connected to a maestro generator and a metriq system then set through critical testing relative to issue.The device was also unexpired and connected to the rhythmia hdx displayed on the workstation.The device appeared on the workstation yet did not appear to be detected on the maestro generator due an open atc.The values of force sensing and direct sense were tested and resulted in normal responsive signals and within the manufacturing standard range.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
Event Description
During an ablation procedure a intellanav stablepoint open-irrigated catheter was selected for use.It was reported that the catheter was connected to the maestro generator, however, the generator was unable to recognize the catheter.The generator was reset and the catheter was reconnected.The error persisted.The catheter was then connected to the osypka generator.Flushing difficult was observed as the pump noticed an occlusion in the system.The catheter was exchanged and the procedure was completed with no patient complications.
 
Event Description
During an ablation procedure a intellanav stablepoint open-irrigated catheter was selected for use.It was reported that the catheter was connected to the maestro generator, however, the generator was unable to recognize the catheter.The generator was reset and the catheter was reconnected.The error persisted.The catheter was then connected to the osypka generator.Flushing difficult was observed as the pump noticed an occlusion in the system.The catheter was exchanged and the procedure was completed with no patient complications.
 
Manufacturer Narrative
The device was returned to boston scientific for analysis.No visual were noted.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.While manipulating the shaft, continuity checks revealed an electrical open in the ablation thermocouple.The device's lumen was leak tested using an isaac pressure decay test system set to 107 psi, and a touhy bourst (tb) seal for sealing the irrigation holes and mini electrodes (me), the lumen pressure decay was measured three times, with re-seating of the tb seal between each test.Lumen pressure decay values were all below the maximum acceptable limit.The device was connected to a maestro generator and a metriq system then set through critical testing relative to issue.The device was also unexpired and connected to the rhythmia hdx displayed on the workstation.The device appeared on the workstation yet did not appear to be detected on the maestro generator due an open atc.The values of force sensing and direct sense were tested and resulted in normal responsive signals and within the manufacturing standard range.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
 
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Brand Name
INTELLANAV STABLEPOINT OPEN-IRRIGATED
Type of Device
CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
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 Key11913654
MDR Text Key253542112
Report Number2134265-2021-07062
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeGM
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 05/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/21/2023
Device Model NumberM004ERFSDS96200
Device Lot Number0027181087
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/08/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/17/2021
Initial Date FDA Received06/01/2021
Supplement Dates Manufacturer Received07/09/2021
04/26/2022
Supplement Dates FDA Received08/05/2021
05/24/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/21/2021
Is the Device Single Use? Yes
Type of Device Usage Unknown
Patient Sequence Number1
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