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	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis revealed: product 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.The device showed 3 kinks located 140.5cm, 149cm and 178.5cm from the tip.There was peeled coating at the 149cm and the 178.5cm locations.The occ handle was connected to the ffr link for signal verification.The signal was present as designed.The occ handle cap was loosened to remove the wire.There was no issue with removing the wire.The sensor housing showed no residue of body fluids.The wire was inserted into the pressure chamber test equipment and the pressure was increased to verify the sensor was indeed reacting to the pressure increases and decreases.The pressure sensor functioned as designed.Inspection of the remainder of the device, apart from the observed damage, revealed no other damage or irregularities.
Event or Problem Description
Reportable based on the product analysis completed on november 21, 2019.It was reported the pressure wire would not zero.A 185cm comet pressure guidewire was selected for use in a fractional flow reserve (ffr) procedure.During preparation for the procedure, outside of the patient, the wire would not zero.The wire was unplugged and plugged back in a couple of times but was still unable to zero.The case was completed using another of the same device with no complications.However, the returned product 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: 9482068
• Report Number: 2134265-2019-15803
• Device Sequence Number: 3987257
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K151610
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2019

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 Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0024244428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/21/2019
• Initial Report FDA Received Date: 12/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1