MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLATIP MIFI XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 87163

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 10/03/2023

Event Type  malfunction  

Event Description

It was reported that before a procedure an intellatip mifi xp catheter was selected for use, however, the device was found contaminated with a foreign substance.The foreign material was contained inside the sterile barrier.The foreign material was loose.It was decided to replace the device, and the issue was resolved.The procedure was completed.No patient complications were reported.The device is expected to return for further analysis.

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.

Manufacturer Narrative

Intellatip mifi xp catheter was evaluated by boston scientific.Visual inspection was performed; the device was returned inside its original unopen pouch and box, and it was observed a foreign material inside the pouch.A dimensional inspection was done on the foreign material; the measure of the foreign material substance is 0.8mm2 and 0.6mm2, the dimensional test failed.Laboratory analysis was able to confirm the reported clinical observation of foreign material present in device.

Event Description

It was reported that before a procedure an intellatip mifi xp catheter was selected for use, however, the device was found contaminated with a foreign substance.The foreign material was contained inside the sterile barrier.The foreign material was loose.It was decided to replace the device, and the issue was resolved.The procedure was completed.No patient complications were reported.The device was returned to boston scientific for laboratory analysis.

• Brand Name: INTELLATIP MIFI XP
• 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: 18021082
• MDR Text Key: 326723030
• Report Number: 2124215-2023-59880
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729848059
• UDI-Public: 08714729848059
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87163
• Device Catalogue Number: 87163
• Device Lot Number: 0030968789
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1