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

Model Number	8900
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a procedure was canceled.A comet device was advanced to perform fractional flow reserve (ffr) diastolic hyperemia-free (dhf) on the anterior descending artery (ada).There was no measurement of values and it was noted that there was a warning of a non existent problem (patient without any arrhythmia).The attempt to perform cardiac catheterization was unsuccessful due to technical problems.No patient complications were reported in relation to this event.
Additional Manufacturer Narrative
Device evaluated by mfr: returned product consisted of an ffr comet pressure wire with the occ cable.The occ cable/handle, tip, device shaft, and sensor port were visually and microscopically examined for damage or any irregularities.Inspection of the device revealed that the tip was stretched.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 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.Product analysis did not confirm the reported event, as the wire was able to get a signal when connected to the ffr link and when connected to the polaris (ilab) test equipment, the wire was able to zero and transferred a pressure waveform, indicating the wire was functioning as designed.
Event or Problem Description
It was reported that a procedure was canceled.A comet device was advanced to perform fractional flow reserve (ffr) diastolic hyperemia-free (dhf) on the anterior descending artery (ada).There was no measurement of values and it was noted that there was a warning of a non existent problem (patient without any arrhythmia).The attempt to perform cardiac catheterization was unsuccessful due to technical problems.No patient complications were reported in relation to this event.

• Brand Name: COMET
• Common Device Name: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 11457554
• Report Number: 2134265-2021-03137
• Device Sequence Number: 4189953
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/04/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0026299096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 03/10/2021
• Supplement Report FDA Received Date: 06/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1