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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/21/2020
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 optical cable connector.The wire shaft showed 2 kinks located 136cm from the tip and at the occ handle.The tip showed a kink and bend.There was peeled coating at the 136cm kinked location.The proximal end of the wire was inspected and there was no fiber optic damage.The sensor inside the sensor port 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.
Event or Problem Description
Reportable based on device analysis completed on 07aug2020.It was reported that a signal issue occurred.During preparation, connection issues with this comet pressure guidewire were noticed while outside the patient.There are no known patient complications.However, 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: 10471539
• Report Number: 2134265-2020-10898
• Device Sequence Number: 2751083
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/31/2020

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: 03/03/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025294893
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 08/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1