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	03/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire shaft showed 1 kink located 162.5cm from the tip and at the occ handle.The tip showed bend damage.There was some peeled coating at the 168.5cm location.The occ cable 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/pressure issues.
Event or Problem Description
Reportable based on analysis completed on 23apr2020.It was reported that the comet wire was not able to zero.This occurred outside the patient and a different device was used to complete the procedure without issue or patient injury.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: 10072475
• Report Number: 2134265-2020-06139
• Device Sequence Number: 19803819
• Product Code: DXO
• UDI-Device Identifier: 08714729904403
• UDI-Public: 08714729904403
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/19/2020

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: 01/09/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025019088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/31/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1