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

Model Number 8900

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/13/2019

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an ffr comet pressure wire connected to the occ handle.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The devices shaft showed 2 kinks located 38cm and 177.5cm from the tip.The tip showed bend damage.There was some slight coating peeled at the 177.5cm location.The occ handle was connected to the ffr link to verify the signal strength.The signal was present as designed.The sensor port showed no residue of body fluids.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 was confirmed to be in specification.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.The wire was inserted into the test pressure chamber and the wire transferred a pd pressure waveform to the polaris which indicates a functioning wire.The wire was removed from the occ handle with no issues.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.

Event Description

Reportable based on analysis completed on 23jan2020 it was reported that drift occurred.The 75% stenosed target lesion was located in the moderately tortuous left anterior descending artery (lad).A comet pressure guidewire was advanced to the target lesion.Fractional flow reserve (ffr) was performed, but the first measurement was 0.93 and a significant drift issue occurred.When performing it for the second time, there was no drift issue observed.The usage of the device was as usual.It was noted that there was a possibility that bubbles were high, which may have contributed to the drift issue.The procedure was completed with the same device.No patient complications were reported in relation to this event.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: 9703792
• MDR Text Key: 179753006
• Report Number: 2134265-2020-00923
• 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: 02/12/2020

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: 09/22/2021
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024479642
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2020
• Initial Date FDA Received: 02/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2019
• 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