MAUDE Adverse Event Report: COOK INC ANGIOGRAPHIC CATHETER; AGENTS EMBOLIC PRODUCT CODE

Catalog Number UNKNOWN

Device Problem Missing Value Reason (3192)

Patient Problems Abdominal Pain (1685); Abscess (1690); Fever (1858)

Event Date 04/04/2016

Event Type  Injury  

Manufacturer Narrative

Suspect device details: 350 to 510 micron poly vinyl alcohol (pva) particles common name: agents embolic product code: naj (b)(6).(b)(4).510k: k081768.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 (mean 54.6).

Manufacturer Narrative

Investigation ¿ evaluation: a review of the interview personnel, documentation and instructions for use (ifu) of the device was conducted during the investigation.Clinical assessment:based on current information, it is feasible to suggest the leading cause of this event is likely patient medical procedure and/or patient disease progression related.The product was not returned, thus a device failure analysis could not be completed.The lot number for this complaint device is unknown.Consequently, the work order record or its related non-conformance's could not be evaluated.Additionally, it could not be determined if other complaints from the same lot have been reported.Additional information provided by the regional manager involved in the study stated that the catheters did not contribute to the liver abscesses.For this reason, the complaint will not be confirmed.Based on the article's information provided, an exact reason for the abscess formation could not be determined.The root cause will be trended as "inconclusive - product functioned as intended" at this time there is no specific device failure or harm reported, therefore no risk assessment can be performed and no risk severity can be assigned.If additional information becomes available, the risk assessment will be updated.

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 (most common bacterium e.Coli) 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 (mean 54 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.The 21 patients were treated with sensitive antibiotics accordingly based on sensitivity test results.The abscess cavity was irrigated once a day for 3 to 5 days after percutaneous catheter drainage (pcd).It was noted that three patients needed 2 drainages and 2 needed 3 drainages.The patients were closely monitored using either abdominal ct scans or ultrasonography every 7 to 10 days until the abscesses were cured or became less than 2 cm in size.Finally, the drainage catheter was pulled out.A total of 20 patients were completely cured from abscesses 15 to 31 days after pcd, but 1 patient died of severe sepsis 9 days after pcd (reference mdr# 1820334-2017-03274).After discharge, all patients were followed up for at least 3 months.Two patients developed complications following pcd: 1 had abscess cavity-bile duct fistula (reference mdr# 1820334-2017-03269), and the other had localized peritonitis reference ( reference mdr# 1820334-2017-03476).No abscess recurrence was observed in all of these patients.For the report addressing the polyvinyl alcohol (pva) particles which was also used in conjunction with the same patient population, please reference mdr# 1820334-2017-03482.It is currently unknown which patients of the 21 had which complications.Additional information has been requested.No allegations of any product malfunction have been alleged.The product is not available for evaluation.Additional information received on 09 nov2017.It was identified per the regional manager involved in the study, "the research was carried out more than 10 years and the objective was to understand the implication of tace and not patient demographic.The cook rh catheter did not cause or contribute to the patients liver abscesses.It is not certain what specific cook rh catheters were used in these procedures.The cook polyvinyl alcohol particles did not cause or contribute to the patients liver abscesses.It cannot be confirmed that cook polyvinyl alcohol particles were used in these procedures.The product did not malfunction in anyway.There are no photos available.Some liver abscesses developed only after the tace procedure and depending on the certain patients outcome after the tace procedure.Medical records are not available as it was more than 10 years".

• Brand Name: ANGIOGRAPHIC CATHETER
• Type of Device: AGENTS EMBOLIC PRODUCT CODE
• 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: 6947729
• MDR Text Key: 89291533
• Report Number: 1820334-2017-03266
• Device Sequence Number: 1
• Product Code: NAJ
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K081768
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2017
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention