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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: IMAGER II ANGIOGRAPHIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC
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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 Consequences Or Impact To Patient (2199)
Date of Event 10/25/2020
Type of Reportable Event Malfunction
Event or Problem Description
It was reported that tip detachment occurred.An imager ii angiographic catheter was selected for a left ventriculography procedure.The imager catheter was loaded onto a.035 x 150 guidewire and prior to insertion into the patient, the tip of the imager catheter detached.The procedure was completed with another of the same device.There were no patient complications.
 
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Brand Name
IMAGER II ANGIOGRAPHIC CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key11003780
Report Number2134265-2020-17643
Device Sequence Number3477613
Product Code DQO
UDI-Device Identifier08714729355885
UDI-Public08714729355885
Combination Product (Y/N)N
Initial Reporter CountryJM
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 Physician
Remedial Action Recall
Type of Report Initial
Report Date (Section B) 12/14/2020
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 Date01/16/2021
Device Model Number38265
Device Catalogue Number38265
Device Lot Number0000137926
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/24/2020
Initial Report FDA Received Date12/14/2020
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured01/16/2019
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
If action reported to FDA under 21 USC 360i(g), list
FDA-assigned Recall Number or include a statement		92484513-FA
Patient Sequence Number1
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