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	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to manufacturer: the comet was returned and analysis was completed.The investigation showed shaft damage in the form of one kink located 54cm from the tip.There was coating peeled from the shaft at this location.It was considered likely that the kink and the peeled coating were attributable to handling issues; therefore, the cause of unintended use error caused or contributed to event was assigned for this damage.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, there was no difficulty in connecting the wire.The guidewire was then inserted into the pressure test fixture.The pressure was raised and lowered to confirm that the wire was reading pressure at the time of return.It was confirmed that the sensor was performing as designed by reading a designated pressure inputted into the test fixture.The coefficient values were confirmed to be in specification and the complaint for zeroing issues were not able to be confirmed, therefore for the initial allegation of failure to zero there was no problem detected.
Event or Problem Description
Reportable based on analysis completed on (b)(6) 2019.It was reported that the 185cm comet pressure guidewire would not zero.This occurred prior to advancing the device into the patient and the device was unable to be used.The procedure was completed by opening another comet wire and the case was completed.The patient is doing well with no complications.However, the returned device analysis revealed some peeling of the device 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: 8514600
• Report Number: 2134265-2019-03665
• Device Sequence Number: 1899664
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 04/15/2019

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 Expiration Date: 08/26/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022567097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 04/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1