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U.S. Department of Health and Human Services

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

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TERUMO MEDICAL CORPORATION TR BAND CLAMP, VASCULAR Back to Search Results
Model Number N/A
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Code Available (3191)
Event Date 02/12/2020
Event Type  Injury  
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. (b)(4). The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record. With no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.
 
Event Description
The user facility reported that the involved tr band was used. There was a radial complication that had occurred. The complication was observed 1. 5 hours after the tr band placement and was so severe that it required a fasciotomy. It sounded like either the band was placed too distal to artery entry site and the doctor took a very aggressive angle for access resulting in a proximal vessel entry site. Additional information was received on 21feb2020. The procedure that was performed prior to the tr band being used was a heart catheterization. A 6fr sheath was used. The radial artery was accessed. The tr band was removed, and an hour and a half later, the patient develop symptoms of compartment syndrome. The patient's condition was stable.
 
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Brand NameTR BAND
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton, md
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
elkton, md
Manufacturer Contact
theresa mussaw
950 elkton blvd.
elkton, md 
2837866718
MDR Report Key9804763
MDR Text Key182520490
Report Number1118880-2020-00006
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K152525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2020
Is this an Adverse Event Report? Yes
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 Received02/12/2020
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 Treatment Data
Date Received: 03/09/2020 Patient Sequence Number: 1
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