MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRA ICE PLUS; CATHETER, ULTRASOUND, INTRACARDIAC

Model Number	86200
Medical Device Problem Codes	Unsealed Device Packaging (1444); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a ultra ice plus was selected to be used in a procedure.However upon opening the box the sterile packageing was in an opened state.The device was replaced and the procedure was completed.
Additional Manufacturer Narrative
Visual inspection of the device showed no damage related to the event was encountered during the visual inspection of the device.The packaging was not returned there for analysis of the sterile bag could not be performed.However media inspection was performed to the pictures sent to boston scientific, in which showed a tear of the sterile bag, thus, confirming the reported allegation.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that a ultra ice plus was selected to be used in a procedure.However upon opening the box the sterile packaging was in an opened state.The device was replaced and the procedure was completed.

• Brand Name: ULTRA ICE PLUS
• Common Device Name: CATHETER, ULTRASOUND, INTRACARDIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12176242
• Report Number: 2134265-2021-09097
• Device Sequence Number: 16365660
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K160173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

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: 02/04/2023
• Device Model Number: 86200
• Device Catalogue Number: 86200
• Device Lot Number: 0026753531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Supplement Date Received by Manufacturer: 10/15/2021
• Initial Report FDA Received Date: 07/15/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown