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

Lot Number 0026874937

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

Patient Problems Unspecified Infection (1930); Swelling/ Edema (4577)

Event Date 12/02/2021

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 sialoadenitis.The patient was unable to talk do to tongue and throat swelling and soreness.The patient was treated with decadron, pepcid, benadryl and solumedrol.The patient was d/c and returned to the hospital (dec 5) with more swelling and was placed on antibiotics and steroids.The patient was stable overnight.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Correction: b3 from 03-dec-2021 to 02-dec-2021.

Event Description

Newton af clinical study ae 1.It was reported that following an ablation procedure with an intellanav stablepoint open-irrigated catheter, the patient experienced sialoadenitis.The patient was unable to talk do to tongue and throat swelling and soreness.The patient was treated with decadron, pepcid, benadryl and solumedrol.The patient was discharged and returned to the hospital two days later with more swelling and was placed on antibiotics and steroids.The patient was stable overnight.Additional information received indicated that a computerized tomography scan was performed during the patient's re-admission and an abscess was observed.Antibiotics and steroids were administered.The suspected cause was secondary to intubation trauma and oral airway dryness.

• 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 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: 13102362
• MDR Text Key: 282909252
• Report Number: 2134265-2021-16187
• 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
• Report Date: 03/03/2022

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
• Device Lot Number: 0026874937
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/02/2022
• 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 Age: 58 YR
• Patient Sex: Female
• Patient Weight: 119 KG