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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK INC ANGIOGRAPHIC CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COOK INC ANGIOGRAPHIC CATHETER LIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number UNKNOWN
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858)
Event Date 04/04/2016
Event Type  Injury  
Manufacturer Narrative
Suspect device details: 4. 0 fr or 5. 0 fr rh drainage catheter. (b)(6). (b)(4). The event is currently under investigation. A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
 
Event Description
It was discovered during a literature review of an observational study titled "liver abscess formation following transarterial chemoembolization" related to a retrospective review of patients from 2005 to 2013, that liver abscesses were found in 21 out of 3613 patients who had undergone a transarterial chemoembolization (tace) procedure. The patients had hepatic malignancies. Among the 21 patients, 15 were males and 6 were females, ranging in age from 41 to 73 years. Nine of these patients had hepatocellular carcinoma (hcc), and 12 had metastatic hepatic tumor (mht). A higher incidence of liver abscess was found in mht patients than in hcc patient. Among these abscess patients, 16 presented with upper abdominal pain, 13 experienced a high grade fever, and 9 had vomiting and nausea. During the physical examination, 11 experienced tenderness in their right upper abdomen, and 8 had localized guarding.
 
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Brand NameANGIOGRAPHIC CATHETER
Type of DeviceLIT CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COOK INC
750 daniels way
bloomington IN 47404
Manufacturer Contact
larry pool
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key6951096
MDR Text Key89366623
Report Number1820334-2017-03612
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 10/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/14/2017
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

Patient Treatment Data
Date Received: 10/16/2017 Patient Sequence Number: 1
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