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

Model Number 8900

Device Problem Output Problem (3005)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Manufacturer Narrative

The tip, device shaft, and sensor port were visually and microscopically examined for damage or any irregularities.The device was kinked 38cm and 158.2cm from the tip and at the occ handle.There was peeled coating at the kinked location 158.2cm from the tip from the torque device.The tip was noticed to be bent.The sensor port showed no residue of body fluids.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.The sensor port was inspected to verify that the sensor was connected to the fiber optic.It was noticed that the sensor was in the correct location in the sensor port.The wire was gently moved back and forth to see if the sensor would move.The sensor did not move which verifies that the fiber optics were connected to the sensor.The proximal end of the wire was inspected for any fiber optic cracks or damage and that it was polished correctly.The wire end showed no damage.The coefficient values were confirmed to be programmed.As a signal issue was confirmed; however, the drift issue that the customer reported could not be confirmed due to the signal issue with the device and due to the clinical circumstances not able to be replicated.The kinks on the device would cause signal issues, as the light from the fiber optics would not pass through the damaged area of the device to the sensor.The tip damage is consistent with the physician shaping the tip for ease of vessel insertion.So the kinks and tip damage were most likely caused by handling of the device during the procedure.

Event Description

Reportable based on device analysis completed on 01oct2020.It was reported that a pressure drift issue occurred.This comet pressure wire was inside the patient when issues were noticed with the pressure drifting.The procedure was completed with a different device with no patient injury.However, device analysis revealed peeled coating.

• Brand Name: COMET
• 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: 10722131
• MDR Text Key: 212987569
• Report Number: 2134265-2020-13874
• Device Sequence Number: 1
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K151610
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/15/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025599721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2020
• 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