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	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date: the event date was note reported.The first date of the month of the aware date was entered as an estimate.The tip, device shaft, sensor port and the coefficient values were examined for damage or any irregularities.The wire showed 4 kinks.The kinks were located 38cm, 60.5cm, 159.5cm from the tip and at the occ handle.There was peeled coating at the 60.5cm location.The tip showed kink damage and stretched coils.The occ handle was connected to the ffr link for signal verification.The signal was not present as designed.The sensor port was inspected to verify that the sensor was connected to the fiber optic.It was noticed that the sensor was in the correct location in the sensor port.The wire was gently moved back and forth to see if the sensor would move.The sensor did not move which verifies that the fiber optics were connected to the sensor.The proximal end of the wire was inspected for any fiber optic cracks or damage and that is was polished correctly.The wire end showed no damage.The coefficient values were confirmed to be programmed.The sensor port showed residue of body fluids.There was evidence of blood on the device.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The equalizing issues were confirmed.
Event or Problem Description
Reportable upon device analysis on 09jun2020.It was reported that the comet gen 1 pressure guidewire was unable to be recognized during procedure.There is no known impact to the patient.The device was returned for analysis.Upon analysis, it was discovered there was 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: 10183641
• Report Number: 2134265-2020-08070
• Device Sequence Number: 886202
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/23/2020

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: 07/29/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022444792
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/23/2020
• Patient Sequence Number: 1