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	No Consequences Or Impact To Patient (2199)
Date of Event	06/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to manufacturer: visual inspection of the returned product (i.E., comet pressure guidewire connected to the optical cable connector, occ) was performed to assess any damage or irregularities associated with the tip, shaft, and sensor port.The device tip showed damage consistent with bending and stretched coils, as well as two kinks (167 and 167.5 cm from the tip).The device coating was also noted to be peeled at the 167.5 cm kink location.There was no body fluid residue noted in the sensor port.No other anomalies were noted with inspection of the remainder of the device.Functional testing was then performed.The occ handle was connected to the ffr link to verify signal strength; signal was present, confirmed via green lights per device design.The occ handle was then connected to bench top testing equipment and the guidewire was inserted in a pressure chamber.The pressure sensor appropriately responded to pressure increases and decreases as designed; coefficient values were consistent with programmed specifications.The occ handle was again connected to the ffr link and then the device was connected to polaris ilab test equipment via bluetooth.The comet guidewire communicated with the polaris system appropriately and zeroed as expected.The guidewire was inserted into the test pressure chamber and transferred a pressure waveform to the polaris system, indicating a functional guidewire.The guidewire was removed from the occ handle with no reported difficulty.Testing revealed that this device was functioning as intended.The observed damage was determined to be likely due to procedural and/or technique-related factors.
Event or Problem Description
Reportable based on analysis completed 15 aug 2020.It was reported that the comet pressure guidewire was not providing a pressure value as intended.There were no patient complications reported.However, returned device analysis revealed peeled coating.

• 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: 10476300
• Report Number: 2134265-2020-12108
• Device Sequence Number: 16864000
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/01/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025478958
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/15/2020
• Initial Report FDA Received Date: 09/01/2020
• Patient Sequence Number: 1