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

Model Number 87047

Device Problems Contamination (1120); Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 05/24/2023

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 prior to a mapping and ablation procedure to treat an atrial flutter (afl) and atrial fibrillation (af), an intellanav mifi open-irrigated catheter was selected for use.When getting ready to start a procedure and product was being pulled, items were being reviewed with another rms and rough plastic on the edges of the packaging was felt as the two devices pulled were picked up.It was then, upon further inspection that the packaging was visibly noticed to have small tears rendering the product unsterile and unusable.When additional catheters were pulled, it was noticed that several others were torn too.Other products that were stored in the same pyxis systems were also inspected and did not find any other products that had flaws.Ultimately, there were two intellanav catheters still in the storage area that were unaffected and was able to use one for the procedure.Procedure was able to be completed successfully without any patient complications.Catheters are expected to be returned for further analysis.

Manufacturer Narrative

Intellanav mifi open-irrigated catheter was evaluated by boston scientific.Visual inspection noted the device does not have visual defects.Is important to mention that the package was not returned for this complaint.Laboratory analysis was unable to confirm the reported clinical observations.Device was found within specifications.

Event Description

It was reported that prior to a mapping and ablation procedure to treat an atrial flutter (afl) and atrial fibrillation (af), an intellanav mifi open-irrigated catheter was selected for use.When getting ready to start a procedure and product was being pulled, items were being reviewed with another rms and rough plastic on the edges of the packaging was felt as the two devices pulled were picked up.It was then, upon further inspection that the packaging was visibly noticed to have small tears rendering the product unsterile and unusable.When additional catheters were pulled, it was noticed that several others were torn too.Other products that were stored in the same pyxis systems were also inspected and did not find any other products that had flaws.Ultimately, there were two intellanav catheters still in the storage area that were unaffected and was able to use one for the procedure.Procedure was able to be completed successfully without any patient complications.Catheters were returned to boston scientific for laboratory analysis.

• 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
• 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: 17176026
• MDR Text Key: 317816957
• Report Number: 2124215-2023-30366
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0031269755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1