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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION IMPULSE GUIDE CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 8201
Medical Device Problem Code Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).
 
Event or Problem Description
It was reported that device sterility was compromised.An impulse guide catheter was selected for use.Prior to procedure, when the sterile package was opened, it was noted to have ripped and was felt to be unsterile.A second multipack was opened and used without difficulty.The procedure was completed with a different device.The patient had no complications and left the lab in good condition.
 
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Brand Name
IMPULSE GUIDE CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8716492
Report Number2134265-2019-07129
Device Sequence Number19301871
Product Code DQO
UDI-Device Identifier08714729200314
UDI-Public08714729200314
Combination Product (Y/N)N
Initial Reporter StateNC
Initial Reporter CountryUS
PMA/510(K) Number
K120495
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 06/20/2019
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 Date03/12/2021
Device Model Number8201
Device Catalogue Number8201
Device Lot Number0060175755
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/30/2019
Initial Report FDA Received Date06/20/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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