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 Problems Hematoma (1884); Pain (1994)

Event Date 02/16/2023

Event Type  Injury  

Manufacturer Narrative

Lot number: requested, unknown.Expiration date: unknown due to unknown lot number.Udi: unknown due to unknown lot number.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date: unknown due to unknown lot number.Occupation: rn, clinical education specialist procedural areas.The actual device was not available for return; therefore, an evaluation of the actual device was unable to be conducted.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.The product lot number was not provided by the user facility, which prevented a meaningful review of the device history record.This report is for the second device reported, for the first device reported that was used on the same patient see mdr 1118880-2023-00027.

Event Description

The user facility reported that the involved tr band was used on a patient post-procedure care when a large hematoma developed.It was stated that they did not believe that the device malfunction caused the hematoma, but the result of the physician, multiple access attempts in different areas of the radial artery.The procedure performed was a percutaneous coronary intervention (pci), right radial access.Multiple attempts were made to gain access to the vessel.Once access was gained a 6fr glide sheath slender was used intra-procedurally.A large tr band was placed post-procedure.A hematoma began forming proximal to the tr band.The doctor moved the tr band more proximally to have the space to be able to place another tr band distally.A hematoma was still forming.Manual pressure was applied along with the two tr bands still on, and then a pressure cuff was placed on top of the more proximal tr band and was clamped at a low pressure to aid in compression.The hematoma was controlled, however the patient complained of hand pain.The patient was kept overnight for observation.Multiple tests were performed to make sure the patient's arm was ok.No intervention was needed, and the patient was discharged.The patient was in stable condition.The procedure outcome was a success.The blood loss was less than 250cc's.Additional information was received on 23 feb 2023: the hematoma was observed at 12:45 and 14:09, repositioned the bands and used a manual cuff for pressure, when starting to release air.When the tr bands were applied 15cc's of air were injected into the first band and 13cc's of air were injected into the second band.The tr bands held the injected air and there appeared to be no damage to either of the tr bands.

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.The complaint can be confirmed for off-label use since the tr band was used to treat the hematoma.The likely root cause of the hematoma is the result of the physician having done multiple access attempts in different areas of the radial artery.The hematoma is not associated with use of the tr band.The device history record (dhr) could not be reviewed since the lot number was not provided.Currently no action is recommended since this risk evaluation is within the predetermined limits in the failure mode and effects analysis (fmea).

• Brand Name: TR BAND
• Type of Device: CLAMP, VASCULAR
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16570880
• MDR Text Key: 311561744
• Report Number: 1118880-2023-00028
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 03/20/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2023
• 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: TRB29-LRG
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/24/2023
• 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: Initial
• Patient Sequence Number: 1
• Treatment: 6FR GLIDESHEATH SLENDER, PRESSURE CUFF
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Sex: Female
• Patient Weight: 106 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White