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	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device returned to manufacturer: the comet pressure guidewire was returned and analysis was completed.The investigation noted that the shaft showed damage in the form of one kink.The kink was located 177cm from the tip of the device.The shaft also showed peeled coating at the 177cm location.The pressure wire was connected to the analysis support test bench and all applicable data was correct as designed, and 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.
Event or Problem Description
Reportable based on analysis completed 03 april 2019.It was reported that the185cm comet pressure guidewire would not zero.The procedure was completed with another of the same device with no patient issues.However, returned device analysis revealed some slight 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: 8492823
• Report Number: 2134265-2019-03465
• Device Sequence Number: 1576069
• 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): 04/08/2019

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: 08/06/2020
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0022480008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2019
• Initial Report FDA Received Date: 04/08/2019
• Patient Sequence Number: 1