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

Catalog Number UNK LIQUID EMBOLIC

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

Patient Problems Ischemia (1942); Muscle Weakness (1967); Paralysis (1997); Urinary Retention (2119)

Event Date 06/30/2004

Event Type  Injury  

Manufacturer Narrative

Manufacturer¿s ref.No: (b)(4).No device was received for analysis at the time of submission of the initial 3500a.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.Device history record (dhr) review cannot be conducted because the lot number was provided by the customer.

Event Description

This complaint is from a literature source.The following complications were reported in this publication: it was reported that 1 patient underwent percutaneous embolization with trufill glue in an attempt to control massive hemoptysis due to pulmonary tuberculosis and suffered a neurological complication.Post-embolization angiography revealed cessation of bleeding.Next morning he developed an inability to move his left leg along with urinary retention.A diagnosis of transverse myelitis (tm) due to spinal ischemia was made and patient started on intravenous dexamethasone.At three months of follow-up the patient had a slight weakness in the left lower limb.Since the embolization he has had no further episode of hemoptysis.Model and catalog number are not available, but the suspected device is trufill nbca glue.Other cnv devices that were also used in this study: n/a.Non-cnv devices that were also used in this study: cordis 4fr cerebral h1 catheter.Publication details: title: percutaneous embolisation and transverse myelitis: a rare association.Objective: tuberculosis (tb) kills approximately 2 million people annually with the developing world bearing the brunt.Massive haemoptysis is a life threatening complication of tb.Percutaneous embolisation is an increasingly practiced method of controlling such bleeding.Most of the literature regarding this technique is based on data from developed countries.Transverse myelitis is the most serious but a very rarely reported complication of this procedure.This is the first such report from the developing world in this regard where percutaneous embolisation may become an increasingly popular method of haemoptysis control for tb.This will result in an associated rise in procedure associated complications thus necessitating increased awareness of such complications.Methods: review of a case report.

• Brand Name: UNK LIQUID EMBOLIC
• 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
• MDR Report Key: 10897780
• MDR Text Key: 218246383
• Report Number: 1226348-2020-00476
• Device Sequence Number: 1
• Product Code: KGG
• Combination Product (y/n): N
• PMA/PMN Number: P990040
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: foreign,literature
• Type of Report: Initial,Followup
• Report Date: 11/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK LIQUID EMBOLIC
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CORDIS 4FR CEREBRAL H1 CATHETER; CORDIS 4FR CEREBRAL H1 CATHETER
• Patient Outcome(s): Required Intervention
• Patient Age: 27 YR