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

Model Number 2404-03

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2020

Event Type  malfunction  

Event Description

It was reported that the procedure was cancelled.This comet ii pressure wire was selected for a fractional flow reserve procedure.During the procedure the pressure waveform value was unable to be displayed.The procedure was not completed due to this event.No patient complications were reported.

Manufacturer Narrative

Device returned to manufacturer: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The device showed multiple kinks and bend throughout the shaft.The tip showed kink damage.The occ handle was connected to the ffr link to verify the signal strength.There were no issues in connecting to the ffr link.The signal was present and showed green lights as designed.The occ handle was then connected to the bench top testing equipment and 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 coefficient values were confirmed to be programmed per document.The occ handle 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.The wire was removed from the occ handle with no issues.The sensor port showed no residue of body fluids.Inspection of the remainder of the device, apart from the observed damage revealed no other damage or irregularities.The complaint was not confirmed for waveform (pressure/signal) issues.

Event Description

It was reported that the procedure was cancelled.This comet ii pressure wire was selected for a fractional flow reserve procedure.During the procedure the pressure waveform value was unable to be displayed.The procedure was not completed due to this event.No patient complications were reported.

• Brand Name: COMET II
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10513650
• MDR Text Key: 206309624
• Report Number: 2134265-2020-12589
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 09/22/2020

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: 05/11/2022
• Device Model Number: 2404-03
• Device Catalogue Number: 2404-03
• Device Lot Number: 0025501808
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2020
• Initial Date Manufacturer Received: 08/12/2020
• Initial Date FDA Received: 09/10/2020
• Supplement Dates Manufacturer Received: 09/22/2020
• Supplement Dates FDA Received: 09/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1