MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET II; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number 2404-01

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 10/04/2021

Event Type  malfunction  

Manufacturer Narrative

Device returned to manufacturer: the device shaft was visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was detached just distal of the weld.The handle of the device was not returned for analysis.Body fluids were present inside the sensor housing.Product analysis confirmed that there was an issue with the device, as the tip was detached.

Event Description

Reportable based on analysis completed 3 nov 2021.It was reported that there had been an unknown issue with the comet pressure guidewire.There were no patient complications reported to have occurred.However, returned device analysis revealed the device was fractured.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12824150
• MDR Text Key: 280951601
• Report Number: 2134265-2021-14417
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729960140
• UDI-Public: 08714729960140
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2023
• Device Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Device Lot Number: 0026878205
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2021
• Initial Date FDA Received: 11/16/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1