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

Model Number 2404-02

Device Problem Communication or Transmission Problem (2896)

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

Event Date 08/02/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.Visual inspection of the device revealed numerous kinks throughout the body of the wire.The wire was separated at the seam weld 38cm proximal of the tip.The separated/detached ends appeared to be bent, indicating that the device was severely kinked prior to separation.The sensor was visible and in the correct location within the sensor housing.The wire was gently shaken to see if the sensor would move and be more visible within the sensor housing.The sensor did not move which verified the sensor was not detached from the fiber optic cable.As it was not reported that the device was detached/separated and the shaft had numerous kinks, it was most likely the shaft/body was separated sometime after the procedure.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that no pressure signal occurred.The comet ii pressure guidewire was used for a diastolic hyperemia-free ratio (dfr)/fractional flow reserve (ffr) study.During the procedure, the comet ii pressure guidewire failed to connect, and a low signal strength led light (color yellow) was shown on the ffr link.The physician attempted a second time, but the connection still failed.The physician's decided to continue with the study the next day.The procedure was completed successfully the next day using a new comet ii pressure guidewire.There were no patient complications reported and the patient condition was stable.However, device analysis revealed a separated/detached wire.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17868017
• MDR Text Key: 324881187
• Report Number: 2124215-2023-53977
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: PE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2404-02
• Device Catalogue Number: 2404-02
• Device Lot Number: 0029548308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2023
• Initial Date FDA Received: 10/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1