MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number M004ERFSDS96200

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected and it was found that the flush line luer was mostly torn and out of place.When the catheter was then functionally tested it was observed that the amount of saline that reached the tip was not sufficient for acceptable irrigation flow.Next the catheter was leak tested and the lumen pressure decay values failed to fall within specifications, indicting a gross leak.With all the available information, boston scientific confirms the allegation the reported complaint.A tear in the flush line could prevent flow from reaching the distal tip, and could lead to the high temperature error observed in the field.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

Event Description

It was reported that during an ablation procedure using an intellanav stablepoint open-irrigated catheter to treat atrial fiburillation the temperature increase alarm occurred and the energization halted.They attempted ablation again, however the alert occurred again so the catheter was removed and examined.There was no thrombus or char present, however, when flushing was performed a leak was confirmed at the base of the flush port on the catheter.They exchanged the catheter and were able to complete the procedure without patient complications.The catheter is expected to be returned for analysis.

• 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 Key: 12508661
• MDR Text Key: 272578935
• Report Number: 2134265-2021-11894
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/21/2021

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 Date: 04/06/2023
• Device Model Number: M004ERFSDS96200
• Device Lot Number: 0027092758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/25/2021
• Initial Date FDA Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1