MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CROSSBOSS; CATHETER, PERCUTANEOUS

Model Number	10592
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the sterile packaging was partly opened.A crossboss re-entry device was selected for use.During preparation, it was noted that the sterile packaging was partly opened at the top corner.The device was not used.The procedure was completed with a different device.No complications reported.

• Brand Name: CROSSBOSS
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10373931
• Report Number: 2134265-2020-10518
• Device Sequence Number: 3120439
• Product Code: DQY
• UDI-Device Identifier: 08714729837510
• UDI-Public: 08714729837510
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K102725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/06/2020

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: 08/02/2020
• Device Model Number: 10592
• Device Catalogue Number: 10592
• Device Lot Number: 0023653289
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1