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U.S. Department of Health and Human Services

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

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TERUMO MEDICAL CORPORATION TR BAND INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Activation, Positioning or SeparationProblem (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.
 
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Brand NameTR BAND
Type of DeviceINTRODUCER, CATHETER
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
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key8939630
MDR Text Key160843500
Report Number1118880-2019-00230
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
UNK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/28/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2019
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

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