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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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BOSTON SCIENTIFIC CORPORATION IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Model Number 38270
Medical Device Problem Code Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 05/01/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Mfr site email: (b)(4).
 
Event or Problem Description
It was reported that a foreign material inside the catheter was observed.An imager angiographic catheter was selected for use for a carotid angiogram in the carotid artery.During preparation when attempting to flush the catheter, it was noted that there was a piece of plastic inside the catheter that popped out upon flushing.The same issue with two other imager catheters.The devices did not enter the patients body.There were no patient complications reported.
 
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Brand Name
IMAGER II ANGIOGRAPHIC CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key8658450
Report Number2134265-2019-06161
Device Sequence Number2446031
Product Code DQO
UDI-Device Identifier08714729354949
UDI-Public08714729354949
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K121694
Number of Events Summarized1
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) 05/31/2019
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 Date03/11/2021
Device Model Number38270
Device Catalogue Number38270
Device Lot Number0000139449
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 05/17/2019
Initial Report FDA Received Date05/31/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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