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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER
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BOSTON SCIENTIFIC CORPORATION SUPER SHEATH INTRODUCER SHEATH; INTRODUCER, CATHETER Back to Search Results
Model Number 220
Medical Device Problem Code Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 03/01/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Date of event: the event date of (b)(6) 2020 is an estimated based of the aware date of (b)(6) 2020 as the exact date was not reported.
 
Event or Problem Description
It was reported that the device was contaminated.A 6fx11cm and 9fx11 cm super sheath introducer sheaths were selected for use for a transcatheter aortic valve replacement procedure.During preparation, a discolored liquid substance inside the packaging of the device was noted.The procedure was completed with another super sheath introducer sheath.No patient complications were reported.
 
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Brand Name
SUPER SHEATH INTRODUCER SHEATH
Common Device Name
INTRODUCER, CATHETER
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key9831054
Report Number2134265-2020-03103
Device Sequence Number11484481
Product Code DYB
UDI-Device Identifier14543527181416
UDI-Public14543527181416
Combination Product (Y/N)N
Initial Reporter CountryUS
Number of Events Summarized1
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) 03/13/2020
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 Date12/31/2021
Device Model Number220
Device Catalogue Number220
Device Lot Number19A29B7
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 03/04/2020
Initial Report FDA Received Date03/13/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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