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

Model Number 86200

Device Problems Unsealed Device Packaging (1444); Material Puncture/Hole (1504)

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

Event Date 06/23/2021

Event Type  malfunction  

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 261801759
• Report Number: 2134265-2021-09097
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 08714729904380
• UDI-Public: 08714729904380
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K160173
• 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: 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1