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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 38265
Medical Device Problem Code Detachment of Device or Device Component (2907)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 12/03/2019
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device eval by manufacturer: returned product consisted of an imager diagnostic catheter in the original pouch.The tip was separated from the shaft.
 
Event or Problem Description
It was reported that the catheter tip broke.The imager ii angiographic catheter was removed from the packaging for review.Upon touching the tip, the tip broke.The device was not used.
 
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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 Key9520275
Report Number2134265-2019-16172
Device Sequence Number3245037
Product Code DQO
UDI-Device Identifier08714729355892
UDI-Public08714729355892
Combination Product (Y/N)N
Initial Reporter CountryCH
PMA/510(K) Number
K120893
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,distri
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 12/26/2019
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 Other
Device Expiration Date09/25/2020
Device Model Number38265
Device Catalogue Number38265
Device Lot Number0000134946
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2019
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 12/03/2019
Initial Report FDA Received Date12/26/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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