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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/10/2020
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.There were 2 kinks located 159.5cm and 164cm from the tip.The tip showed stretched coils.There was peeled coating at the 159.5cm location.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 guidewires distal tip was removed to view the sensor inside the shaft and view for damage.The sensor showed no damage.The coefficient values were confirmed to be programmed.The sensor port showed no residue of body fluids.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.The failure to recognize zero pressure was confirmed.
Event or Problem Description
It was reported that failure to zero a pressure guidewire occurred.During preparation of a diastolic fractional reserve (dfr) and while outside the patient, dedicated steps were performed to connect a comet pressure guidewire to an ffr link, but the pressure guidewire would not zero.It was noted that turning the ffr link off and on again did not resolve the issue.The comet wire was exchanged and the procedure was completed with another of the same device.No patient complications were reported in relation to this event.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: 10476860
• Report Number: 2134265-2020-12091
• Device Sequence Number: 3672315
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 09/01/2020

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: 02/17/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025226215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 09/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1