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

Model Number	8900
Medical Device Problem Code	Failure to Zero (1683)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the product was returned to boston scientific for analysis.Returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire shaft showed 1 kink located 142.5cm from the tip.There was some peeled coating at the 142.5cm location.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.Device analysis was conducted by inspecting the proximal end of the wire for any damage to the fiber optic.No damage was noticed.The sensor was inspected by viewing the sensor port to verify that the sensor was in the correct location.This sensor looked to be too far distal which would give the indication of the sensor being detached from the fiber optic cable.The wire was gently shaken to see if the sensor would move within the sensor housing and the sensor did move which verifies the sensor was detached from the fiber optic.The coefficient values were confirmed to be programmed.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.Device analysis determined the condition of the returned device was consistent with the reported information of signal zero issues.
Event or Problem Description
It was reported that failure to zero a pressure guidewire occurred.During preparation and outside the patient, a comet pressure guidewire was plugged into an ffr link, but it did not zero.The ffr link zero light was flashing red.Another comet wire was opened, and it zeroed.The case proceeded and an intervention was performed as needed.Another comet was later used.The comet had the same issue and was not able to zero after it was plugged into the ffr link.In another room, the comet wires were connected to the ffr link to help determine whether or not the issue was with the ffr link and not the comet wires.The comet wires that were tested were unable to zero after they were plugged into the ffr link.It was noted that the comet wires were seated correctly in the ffr link and the workflows were followed correctly.No patient complications were reported in relation to this event.However, a comet device returned and 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: 10010540
• Report Number: 2134265-2020-05699
• Device Sequence Number: 11487419
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/29/2020

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: 01/25/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025105829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2020
• Initial Report FDA Received Date: 04/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1