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 Contaminated During Manufacture or Shipping (2969)

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

Event Date 05/17/2022

Event Type  malfunction  

Event Description

It was reported that during preparation for a procedure using a intellatip mifi xp catheter there was foreign material inside the sterile packaging.They replaced the catheter and were able to complete the procedure without patient complications.The catheter is expected to be returned for 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

Upon receipt at boston scientific's post market laboratory the catheter and its sterile packaging was first visually inspected and the foreign material was found.The material was outside of the sterile pouch, stuck between the label and the exterior of the pouch.\the reported allegation was confirmed.

Event Description

It was reported that during preparation for a procedure using a intellatip mifi xp catheter there was a suspected foreign object contamination.They replaced the catheter and were able to complete the procedure without patient complications.The catheter was received for 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: 14676218
• MDR Text Key: 294260913
• Report Number: 2134265-2022-06745
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/13/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/12/2024
• Device Model Number: 87163
• Device Catalogue Number: 87163
• Device Lot Number: 0026623014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2021
• 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