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

Model Number	10594
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the package seal was compromised.A stingray lp catheter re-entry device was selected for use.During preparation, it was noted that the package seal of the device was not fully sealed.Product sterility was questioned.The procedure was completed with another of the same device.No patient complications reported.

• Brand Name: STINGRAY LP
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10443343
• Report Number: 2134265-2020-11546
• Device Sequence Number: 2726935
• Product Code: DQY
• UDI-Device Identifier: 08714729903352
• UDI-Public: 08714729903352
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K152401
• 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): 08/24/2020

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: 03/11/2022
• Device Model Number: 10594
• Device Catalogue Number: 10594
• Device Lot Number: 0025344246
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/06/2020
• Initial Report FDA Received Date: 08/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1