MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OI

Model Number 87045

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354)

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

Event Date 09/14/2022

Event Type  malfunction  

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 oi was selected for a redo pulmonary vein isolation (pvi) procedure.During preparation while flushing, there was a leak shown up next to the luar.The catheter was exchanged and the procedure was completed.

Manufacturer Narrative

Visual inspection of the device showed no evidence of the reported event since the unit passed the leak test; no leakage was found during the analysis; therefore, the reported complaint was not confirmed.During flow test, an obstruction was found in the device.A dissection was performed, and some crystal-shaped residues were found in the irrigation channels, and they were analyzed if they were contrast medium.The crystals were exposed to in the x-ray testing, and it was noticed that they were radiopaque since they absorbed the radiation and had a high density in the expose area.

Event Description

It was reported that a intellanav oi was selected for a redo pulmonary vein isolation (pvi) procedure.During preparation while flushing there was a leak next to the luer.The catheter was exchanged, and the procedure was completed.

• Brand Name: INTELLANAV OI
• Type of Device: INTELLANAV OI
• 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: 15503059
• MDR Text Key: 304844663
• Report Number: 2124215-2022-38502
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0028589199
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1