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

Model Number 2404-04

Device Problems Stretched (1601); Communication or Transmission Problem (2896); Material Deformation (2976)

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

Event Date 01/26/2024

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The first photo shows that the tip had slight bends and was stretched with a partial detachment at the end of the tip by the sensor housing.The second photo is the fluro and showed the wire, but you couldn't tell from the photo if the wire was damaged.The third photo showed no pd value on the polaris ilab screen.The shroud of the occ cable was connected to the bench top testing equipment.The rfid tag associated with this device is e004010841e7ea38 and the coefficient values were confirmed to be programmed.Visual inspection revealed that here was no tip attached to the wire.The shroud of the occ cable was connected to the ffr link for signal verification.The signal was not present, as designed.During testing with the ffr link, the 'signal strength' led showed a yellow/orange light and the 'zeroed' led showed a blinking red light, indicating that the wire was not working appropriately.The led lights for a properly working wire are green.The shroud of the occ cable was connected to the bench top testing equipment.The modulation was checked but there was no modulation (0%) for this device.Microscope inspection revealed that the tip was detached at the sensor housing.Inspected the sensor by viewing the sensor port to verify that the sensor was in the correct location.The sensor appeared to be inside the sensor housing detached from the fiber optic cable.The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verifies the sensor was detached from the fiber optic.The proximal end face of the wire showed the proximal end face was cracked/damaged.When the handle was dismantled, it was found that the proximal end of the wire appears to have punctured the polymer disc.With the proximal end of the wire damaged, the handle was dismantled to see if there was any damage or irregularities.

Event Description

Reportable based on device analysis completed on 03apr2024.It was reported that the wire got stretched and kinked.The 80% stenosed target lesion was located in the mildly tortuous and calcified left anterior descending artery.It was reported that the pd signal was missing after the device crossed the lesion.The device was simply pulled out and noticed the tip of the wire got kinked and stretched.The procedure was completed with another of the same device.No patient complications were reported.However, device analysis revealed that the tip was detached at the sensor housing.

• Brand Name: COMET II
• Type of Device: ER, 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: 19142566
• MDR Text Key: 340624045
• Report Number: 2124215-2024-23728
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/19/2024

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: 05/10/2024
• Device Model Number: 2404-04
• Device Catalogue Number: 2404-04
• Device Lot Number: 0029383222
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/11/2022
• 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
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 60 KG