MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TR BAND; INTRODUCER, CATHETER

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Hematoma (1884); Blood Loss (2597)

Event Date 08/05/2019

Event Type  malfunction  

Manufacturer Narrative

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.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 and complaint files.

Event Description

The user facility reported that the involved tr band caused a patient to develop a hematoma in recovery, not in the lab.They feel like the band is not as secure.It was reported that that the tr band felt stiffer.The estimate blood loss was less than 250cc.The patient was in stable condition and recovered.The procedure outcome was successful.Additional tr band was used.Additional information was received 8august2019: it was reported that the issue with the tr band had more to with the stability of the band, it moves around on the patient.A dark line appeared in the middle of the patients arm and a hematoma began to form.Additional information was received 16august2019: it was observed that the tr bands are too tight and displaced on the artery as they inflate the balloon.The tr band is left on for a one hour diagnostic, and two hours interventional.The exact location of the hematoma is on the forearm.The inflation volume to start is 15, then they back it off until a flash and then re-enter at 1-2cc.There is no slow leaks associated with the band.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, the exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: TR BAND
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8939630
• MDR Text Key: 160843500
• Report Number: 1118880-2019-00230
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• PMA/PMN Number: UNK
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2019
• Is this an Adverse Event Report?: No
• 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: 09/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1