MAUDE Adverse Event Report: CODMAN AND SHURTLEFF, INC EMBOLIC AGENT; TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS

Catalog Number UNK EMBOLIC AGENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Code Available (3191)

Event Date 09/16/2019

Event Type  Injury  

Manufacturer Narrative

Product complaint # (b)(4).Surgical intervention.Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.Missing information from this report is identified as blank; this information was not provided in the reported event or available at the time of report submission.- attachment:(b)(4).

Event Description

This complaint is from a literature source.As reported in the literature publication entitled, ¿intranodal glue embolization for the management of postsurgical groin lymphocele and lymphorrhea¿ 2 patients with groin lymphatic leaks who underwent intranodal lymphatic embolization which was performed by intranodal injection with dilute n-butyl cyanoacrylate (nbca) failed embolization.The patients were handled by successful laparoscopic unroofing at 2 months and lymphatic ligation.This report describes intranodal lymphatic embolization for treatment of groin lymphatic leaks following surgery or percutaneous vascular interventions.Imaging and medical records of 10 consecutive patients (6 men; median age 66 y) who presented with groin lymphatic leaks and underwent intranodal lymphangiography and embolization between 2015 and 2017 were reviewed.Groin lymphatic leaks were defined as presence of a lymphocele with draining catheter or groin lymphorrhea manifesting as weeping of fluid from the access point and/or wound.Nbca liquid embolic agent trufill was used in this study.No device specific information (including catalog and lot number) was provided in the article.

• Brand Name: EMBOLIC AGENT
• Type of Device: TISSUE ADHESIVE FOR USE IN EMBOLIZATION OF BRAIN ARTERIOVENOUS MALFORMATIONS
• Manufacturer (Section D): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA 02767
• Manufacturer (Section G): CODMAN AND SHURTLEFF, INC; 325 paramount dr; raynham MA
• Manufacturer Contact: gabriel alfageme ; 31 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 9168383
• MDR Text Key: 170179486
• Report Number: 1226348-2019-00997
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK EMBOLIC AGENT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR