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: Physician
• Type of Report: Initial
• Report Date: 10/16/2017

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2017
• Initial Date FDA Received: 10/16/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention