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

Model Number N/A

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

Patient Problem Hematoma (1884)

Event Date 10/29/2020

Event Type  Injury  

Manufacturer Narrative

Patient identifier -(b)(6).The actual device was not returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.

Event Description

The user facility reported that the involved tr-band was used.The physician performed a percutaneous coronary intervention (pci) due to stemi.The right radial artery was accessed with a glidesheath slender 6fr.Anterior wall kit without issue.The pci was performed successfully, and the sheath was removed, and the tr band was placed at the site per ifu.The physician ordered heparin drip due to residual clot and the patient was transferred to pre/post recovery unit.One-hour post placement of the tr band, a hematoma began to form proximal to the band and was described as thumb size.The pre/post staff "pushed out" or massaged the hematoma and wrapped with s coband to mid-arm to apply pressure.After 15 minutes the coband was removed and the hematoma was assessed and noted that it was firm outside of the marked area.A second tr band was placed proximal to the first on the hematoma to apply pressure.After 10 minutes, the hematoma expanded beyond the second tr band and it was decided to replace the coband above the second tr band.The coband was left on the hematoma for 45 minutes then removed.The hematoma was noted to have grown about hallway up the arm, thus a blood pressure cuff was applied on the forearm and inflated to 145.It was noted the distal tr band had slipped down the wrist and was displaced distal to the access site.The staff deflated the tr band and moved it back to original placement and placed the green dot 3 mm proximal to the skin site at which point a laceration was noticed on the wrist.It was determined the laceration was about half an inch in size and was caused by the edge of the tr band.Gauze was placed over the laceration to provide comfort to the patient.Heparin drip was stopped, and hemostasis was achieved after 15 minutes.The hematoma was noted to have stopped growing and was soft.The physician ordered to follow "normal" protocols for deflation and the staff executed.After full deflation of the tr band balloon, heparin drip was ordered to start again.Patient was transferred to icu and was monitored overnight.The estimated blood loss was less than 250cc's.There was no patient injury, medical/surgical intervention required.The patient's condition was stable, and the procedure outcome was successful.Additional information was received on 09nov2020.There is no allegation against the second tr band.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.It is likely that the combination of the improper placement of the tr band on the patient's wrist and the heparin drip, making the patient's blood less prone to clotting, is the likely cause of the complaint event.The skin tear that was noted from the edge of the 1st tr band was likely caused by the tr band when it moved on the patient's wrist (possibly from patient bending their wrist or from initial improper placement of the tr band).It is likely the patient's wrist rubbed up against the rigid plate of the tr band causing a small skin tear.The complaint can be confirmed for procedural complication based on the severity of the complaint event.Based on the information given, the exact root cause of the event cannot be determined.Currently, no action is recommended since this risk evaluation is within the predetermined limits in the fmea.

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 10867925
• MDR Text Key: 217100946
• Report Number: 1118880-2020-00303
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: HEPARIN; HEPARIN
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR
• Patient Weight: 64