• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems High Blood Pressure/ Hypertension (1908); Nerve Damage (1979)
Event Date 02/19/2024
Event Type  Injury  
Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
 
Event Description
It was reported that during an ablation procedure using a intellanav stablepoint open-irrigated catheter the patient experienced phrenic nerve palsy (pnp) post-procedure.A pulmonary vein isolation and cavotricuspid isthmus ablation was performed with the rhythmia mapping system and the intellanav stablepoint open-irrigated catheter.Pacing from ablation catheter was performed during pvi on the right side anterior-superior.The case was completed without complications.However, the patient was hypotensive after the procedure with blood pressure issues observed in the ward.The physicians suspected internal bleeding for which they referred the patient to a ct scan.Outcome from the ct scan showed phrenic nerve injury due to lung placement no visible internal bleeding.Hence, they noted that the lung placement was much higher than normally, and volume was much lower than compared to the lung on the left side.The patient was discharged on (b)(6) 2024 and their condition is ongoing.Device will not returned as it has been disposed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key18799027
MDR Text Key336459355
Report Number2124215-2024-11835
Device Sequence Number1
Product Code OAE
Combination Product (y/n)N
Reporter Country CodeFI
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/28/2024
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
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/21/2024
Initial Date FDA Received02/28/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
-
-