MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION COMET; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number	8900
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/25/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a shaft break occurred.This comet pressure guidewire was selected for preparation; however, when removing the device from its box the shaft broke.The procedure was completed with another of the same device.
Event or Problem Description
It was reported that a shaft break occurred.This comet pressure guidewire was selected for preparation; however, when removing the device from its box the shaft broke.The procedure was completed with another of the same device.It was further reported that the break occurred at the proximal portion of the wire, close to the connection with the bluetooth hub.

• 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: 9811808
• Report Number: 2134265-2020-02418
• Device Sequence Number: 16923890
• Product Code: DXO
• UDI-Device Identifier: 08714729904397
• UDI-Public: 08714729904397
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,Followup
• Report Date (Section B): 04/13/2020

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: 01/21/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025088136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/25/2020
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 03/10/2020
• Supplement Report FDA Received Date: 04/13/2020
• Patient Sequence Number: 1