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 Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign object was found inside the sterilization bag after unpacking the box containing the intellatip mifi catheter.When the bag was checked closely, there were plastic pieces found.Since the coating of the main unit handle peeled off, it is possible that it was part of the plastic pieces.No patient complications were reported.A different catheter was used to complete the procedure.
Event or Problem Description
It was reported that a foreign object was found inside the sterilization bag after unpacking the box containing the intellatip mifi catheter.When the bag was checked closely, there were plastic pieces found.Since the coating of the main unit handle peeled off, it is possible that it was part of the plastic pieces.No patient complications were reported.A different catheter was used to complete the procedure.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection showed that particles of a foreign material were encountered inside the sealed pouch and around the steering knob, and the residues found looked similar between them.The particles found matched with the foreign material observed in the pictures provided by the customer.During the manufacturing process, the device was not correctly assembled, due to foreign materials found in the edges of the sealed pouch and around the steering knob.

• Brand Name: INTELLATIP MIFI XP
• Common Device Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12032055
• Report Number: 2134265-2021-07891
• Device Sequence Number: 3411470
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/02/2021

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: 12/07/2023
• Device Model Number: 87162
• Device Catalogue Number: 87162
• Device Lot Number: 0026475833
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2021
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 06/21/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1