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

Model Number 2404-01

Device Problem Contamination (1120)

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

Event Date 02/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: estimated based on aware date of (b)(6) 2021.

Event Description

It was reported that contamination occurred.A fractional flow reserve (ffr) procedure was being completed.A comet ii pressure guidewire was opened but the product was noted to be contaminated prior to use.No adverse patient effects occurred as a result of this event.

• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 11409016
• MDR Text Key: 234685317
• Report Number: 2134265-2021-02651
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2021

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 Model Number: 2404-01
• Device Catalogue Number: 2404-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1