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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC CORPORATION STINGRAY LP CATHETER, PERCUTANEOUS Back to Search Results
Model Number 10594
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2020
Event Type  Malfunction  
Event 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.

 
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Brand NameSTINGRAY LP
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC SCIMED, INC
two scimed place
maple grove MN 55311
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10443343
MDR Text Key204047923
Report Number2134265-2020-11546
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK152401
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 08/24/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10594
Device Catalogue Number10594
Device LOT Number0025344246
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/06/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/11/2020
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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