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); Pseudoaneurysm (2605); Swelling/ Edema (4577)

Event Date 03/21/2022

Event Type  Injury  

Event Description

The user facility reported that they discovered a hematoma above the tr band in recovery.The patient arrived in recovery with a hematoma.They applied a bp cuff just above the hematoma.Swollen from thumb to mid-forearm.They removed tr band to do an ultrasound.Duplex showed pseudo-aneurysm and the patient went to the operating room (or) for vascular surgery.The patient was discharged.Post procedure hematoma and surgical intervention required.Additional information was received on 30 mar 2022: the procedure performed prior to using the tr band was a left/right heart catheterization.There were 11ml's of air injected into the tr band when it was applied.There was no noticeable damage to the device.The patient was in stable condition.Surgical intervention was successful.

Manufacturer Narrative

Implanted date: device was not implanted.Explanted date: device was not explanted.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.A review of the device history record of the product code/lot# combination was conducted with no findings.

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 since medical intervention was used to treat the hematoma and pseudo aneurysm.The exact root cause cannot be confirmed.The likely root cause is failure to adequately monitor the patient's condition.The dhr review determined that the device was in a conforming state when released from terumo control.There is no indication that any manufacturing issues may have led to this event.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
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 14163443
• MDR Text Key: 289878193
• Report Number: 1118880-2022-00023
• Device Sequence Number: 1
• Product Code: DXC
• UDI-Device Identifier: 00389701011349
• UDI-Public: 00389701011349
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2024
• Device Model Number: N/A
• Device Catalogue Number: TRB24-REG
• Device Lot Number: 0000102801
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2021
• 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: BP CUFF
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 89 YR
• Patient Sex: Female