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	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: the returned product consisted of an ffr comet pressure wire connected to the occ cable.The tip, device shaft and sensor port were examined for damage or any irregularities.The wire shaft showed 2 kinks located 38cm and 139cm from the tip.Peeled coating on the shaft was noticed at the 139cm location.The tip showed bend damage.The occ cable was connected to the ffr link for signal verification.The signal was not present as designed.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.
Event or Problem Description
It was reported that signal issues with a pressure guidewire occurred.During preparation and while outside the patient, a comet device was connected to the console, but no pressure signal occurred.It was noted that the guidewire did not light up at the console, and the light on the console was red.Another comet was used to complete the procedure.No patient complications were reported in relation to tis event.However, the device was 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: 10676748
• Report Number: 2134265-2020-14095
• Device Sequence Number: 2626938
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 10/14/2020

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: 01/27/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025120425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2020
• Initial Report FDA Received Date: 10/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1