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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hematoma (1884); Hemorrhage/Bleeding (1888)

Event Date 12/03/2021

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

(b)(6).It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.

Manufacturer Narrative

F.10 patient codes: corrected from hematoma e0505 to hemorrhage/bleeding e0506.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

Newton af clinical study ae 2.It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.

Manufacturer Narrative

Additional information was added to b5.It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.

Event Description

Newton af clinical study clinical study id: (b)(4), subject id: (b)(6).It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced bleeding at the drain site.Pressure was applied and dressing was reinforced.The patient was placed in head of bed flat.The bleeding was resolved by administering an injection of lido/epi and silver nitrate.Additional information received indicates that the patient was discharged on (b)(6) 2021.

• Brand Name: INTELLANAV STABLEPOINT OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 13102294
• MDR Text Key: 282909017
• Report Number: 2134265-2021-16188
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2021
• 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
• Date Manufacturer Received: 05/02/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Female