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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 38270
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 07/17/2020
Type of Reportable Event Serious Injury
Event or Problem Description
It was reported that tip detachment occurred.A 5fr imager ii angiographic catheter was selected for a uterine artery embolization procedure.A femoral approach was used to access the mildly calcified eccentrically shaped lesion.The anatomy was not tortuous.During the procedure, approximately 3-5cm of the tip of the catheter detached inside the patient and was visible on fluoroscopy.The tip was retrieved using a snare.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.
 
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Brand Name
IMAGER II ANGIOGRAPHIC CATHETER
Common Device Name
CATHETER, INTRAVASCULAR, DIAGNOSTIC
MDR Report Key11003788
Report Number2134265-2020-17438
Device Sequence Number3477616
Product Code DQO
UDI-Device Identifier08714729354963
UDI-Public08714729354963
Combination Product (Y/N)N
Initial Reporter CountryIN
PMA/510(K) Number
K121694
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? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Expiration Date08/27/2021
Device Model Number38270
Device Catalogue Number38270
Device Lot Number0000144528
Was Device Available for Evaluation? No
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/26/2020
Initial Report FDA Received Date12/14/2020
Was Device Evaluated by Manufacturer? (Y/N) Device Not Returned to Manufacturer
Date Device Manufactured08/27/2019
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
Outcome Attributed to Adverse Event Required Intervention;
Patient Age41 YR
Patient Weight68
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