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

Model Number	8900
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package was not sealed.During a diagnostic left heart cath and while outside the patient, it was noticed that a comet pressure guidewire package was not sealed.The comet device was not used and the procedure was successfully completed.No patient complications resulted in relation to this event.

• 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: 10837794
• Report Number: 2134265-2020-15661
• Device Sequence Number: 14488571
• Product Code: DXO
• UDI-Device Identifier: 08714729875758
• UDI-Public: 08714729875758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/13/2020

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: 01/16/2022
• Device Model Number: 8900
• Device Catalogue Number: 8900
• Device Lot Number: 0025060153
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2020
• Initial Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1