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

Model Number 2404-03

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/13/2022

Event Type  Injury  

Event Description

It was reported a thrombus occurred.A coronary artery graft procedure was being performed on a 75% stenosed mildly calcified and moderately tortuous left anterior descending artery.An imaging catheter and comet ii pressure guidewire were used.When performing fractional flow reserve (ffr), a thrombus appeared on the comet ii pressure guidewire.The comet ii pressure guidewire and the imaging catheter were removed from the body and the thrombus was rinsed off.The ffr was then quickly performed again and it was completed successfully.The physician thought there was a possibility that the coating of the comet was defective; however, there was no confirmation.

Manufacturer Narrative

This is no longer a reportable complaint based on the further information received which is highlighted in b5.Device evaluated by mfr: returned product consisted of an ffr comet pressure wire.The occ cable was not returned for analysis.The tip, device shaft, and sensor were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was bent and kinked.The appearance of the confirmed damage is consistent to damage that can be caused from interaction with another device or patient anatomy during the procedure.There was no thrombosis on the outside of the device but there were body fluids inside the sensor housing.Also, there was no damage or irregularities to the coating of the device.The wire was connected to the handle of a test occ cable.The shroud of the test occ cable was connected to the ffr link to verify the signal strength.The signal was present and the signal strength and zeroed showed green lights, as designed.The occ cable was then connected to the bench top testing equipment.The modulation was 11.8% and the coefficient values were confirmed to be programmed.The wire was inserted into the pressure chamber.The pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.The shroud of the occ cable was again connected to the ffr link.The device was then connected to the polaris (ilab) test equipment via bluetooth signal.The wire communicated to the polaris system and zeroed, as designed.With the wire inserted into the test pressure chamber, the wire transferred a pressure waveform to the polaris which indicates a functioning wire.Product analysis could not confirm the reported event, as the clinical circumstances could not be replicated.However, there was body fluids in the sensor housing and the tip was damaged.

Event Description

It was reported a thrombus occurred.A coronary artery graft procedure was being performed on a 75% stenosed mildly calcified and moderately tortuous left anterior descending artery.An imaging catheter and comet ii pressure guidewire were used.When performing fractional flow reserve (ffr), a thrombus appeared on the comet ii pressure guidewire.The comet ii pressure guidewire and the imaging catheter were removed from the body and the thrombus was rinsed off.The ffr was then quickly performed again and it was completed successfully.The physician thought there was a possibility that the coating of the comet was defective; however, there was no confirmation.It was further reported that the thrombus was not in the blood vessel or on the comet device, but it was inside the non-boston scientific imaging catheter.Therefore, this is not a reportable event against the comet device.

• 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 ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15577090
• MDR Text Key: 301498156
• Report Number: 2124215-2022-40498
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2022

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?: No
• Device Operator: Health Professional
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0029588139
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/13/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/10/2022
• Supplement Dates FDA Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/14/2022
• 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 Outcome(s): Other