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

Model Number 87047

Device Problem Data Problem (3196)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 07/16/2020

Event Type  Injury  

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

It was reported that a intellanav mifi open-irrigated was used in a posterior wall ablation procedure.However during the procedure after 200 ablations it was noted that loss of visualization of the catheter occurred.Trouble shooting was performed buy replacing the backpatches which didn't resolve the issue.The catheter was replaced and the procedure was completed.However as the patient was waking up from the anesthesia it was noted that the patient had low blood pressure occurred.The patient was given transesophageal echo and fluid over flow was noted but no effusion, arterial blood gases (abgs).The patient was given various medications causing the patient to be admitted to the hospital beyond standard care.

Event Description

It was reported that a intellanav mifi open-irrigated was used in a posterior wall ablation procedure.However during the procedure after 200 ablations it was noted that loss of visualization of the catheter occurred.Trouble shooting was performed buy replacing the back patches which didn't resolve the issue.The catheter was replaced and the procedure was completed.However as the patient was waking up from the anesthesia it was noted that the patient had low blood pressure occurred.The patient was given transesophageal echo and fluid over flow was noted but no effusion, arterial blood gases (abgs).The patient was given various medications causing the patient to be admitted to the hospital beyond standard care.

Manufacturer Narrative

The returned device was reported for tracking issues and the being involved with a low blood pressure outcome.Evaluation of the device returned tracking errors.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.A risk review was completed and confirmed that the event of hypotension was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.There is no evidence this device was used in a manner inconsistent with the labeled indications.

• Brand Name: INTELLANAV MIFI 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
• MDR Report Key: 10344313
• MDR Text Key: 201075893
• Report Number: 2134265-2020-10206
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/17/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0024778274
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Date Manufacturer Received: 10/24/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR