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

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.

• Brand Name: ANGIOGRAPHIC CATHETER
• Type of Device: LIT 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 Key: 6951096
• MDR Text Key: 89366623
• Report Number: 1820334-2017-03612
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: CN
• Number of Events Reported: 1
• 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 Received: 10/16/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: UNKNOWN
• 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 Received: 09/14/2017
• 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