MAUDE Adverse Event Report: TERUMO MEDICAL CORP. TR BAND; CLAMP, VASCULAR

Model Number TRB24-REG

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

Patient Problems Air Embolism (1697); Cardiopulmonary Arrest (1765); Stroke/CVA (1770); Paresis (1998); Weakness (2145); No Code Available (3191)

Event Date 08/18/2016

Event Type  Injury  

Event Description

Patient was admitted for a planned heart catheterization as part of a lung transplant candidacy evaluation.The patient underwent the procedure via access through a sheath (terumo 6 french glide sheath slender sheath.Catalogue # rmrs6f10pa) at the radial artery.At the conclusion of procedure, the sheath is removed from the radial artery.Pressure is applied to the radial artery for 30 minutes by an inflatable device which helps prevent the development of a hematoma at the radial artery site.The device, called a tr band, is specifically designed for radial artery compression.The device wraps around the site, is inflated by means of a syringe that is supplied with the device.The tr band has a port that is compatible with the supplied syringe.The syringe is designed to not be compatible with iv luer loks.The sheath has an access point at its top which is used to introduce guidewires, stents, balloons and other devices used during cardiac catheterization.This access site is not a luer lok type of iv access and will accept a narrow, straight syringe tip, although not securely.An interventional cardiology fellow was removing the sheath from the radial artery.The fellow placed approximately 18cc of air (full volume of terumo tr band syringe) into what was believed to be the tr band port to inflate the band over the radial artery site.Immediately after placing the air, the patient became non-responsive but did not lose a pulse.A code was called.A neurological evaluation revealed left visual field neglect or visual loss, mild left gaze paresis, and mild 4/5 weakness in the left arm and leg, and some left-sided sensory loss and apparent left neglect.A head ct was performed which did not reveal an acute intercranial process.The patient was admitted to the neuroscience intensive care unit (icu).Despite the reassuring head ct, the patient was presumed to be having a stroke from the air embolism.The patient recovered well during the short hospital course.By the time of discharge her neurologic exam was almost completely normal except for some very mild neglect of the left side.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd; elkton MD 21921
• MDR Report Key: 5924161
• MDR Text Key: 53799952
• Report Number: 5924161
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Physician
• Device Model Number: TRB24-REG
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/25/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 08/25/2016
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR
• Patient Weight: 64