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

Model Number	87162
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/21/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
It was reported that a black foreign object was found inside the sterile catheter packaging.During preparation for an atrial flutter ablation procedure, a black foreign object was found inside the sterile catheter packaging.The device was not used for the procedure and another of the same catheter was used.No patient complications were reported and the patient's current condition is fine.
Event or Problem Description
It was reported that a black foreign object was found inside the sterile catheter packaging.During preparation for an atrial flutter ablation procedure, a black foreign object was found inside the sterile catheter packaging.The device was not used for the procedure and another of the same catheter was used.No patient complications were reported and the patient's current condition is fine.
Additional Manufacturer Narrative
The device was returned with its original box and it was located inside the original sealed pouch.Visual inspection revealed a small black piece of a foreign matter within the sealed pouch.The foreign matter moves freely within the sealed pouch.It was confirmed that the foreign matter within the sealed pouch is greater than the 0.30 square millimeters.

• Brand Name: INTELLATIP MIFI XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8420025
• Report Number: 2134265-2019-02468
• Device Sequence Number: 11275588
• Product Code: OAD
• UDI-Device Identifier: 08714729848042
• UDI-Public: 08714729848042
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020025
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/25/2021
• Device Model Number: 87162
• Device Catalogue Number: 87162
• Device Lot Number: 0022431525
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/26/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 05/21/2019
• Patient Sequence Number: 1