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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 Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
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.
 
Event Description
Terumo medical received a user facility medwatch report #1900450000-2019-8023. The event description states: as case ended, the tr band was applied to the site of the sheath in the radial artery. The tr band was inflated to normal pressure. At this time, the balloon on the band burst while on the patient. The original procedure was left heart catheterization (lch), ffr and coronary stent placement.
 
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Brand NameTR BAND
Type of DeviceCLAMP, 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
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key9595755
MDR Text Key199313094
Report Number1118880-2019-00372
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,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2021
Device Model NumberN/A
Device Catalogue NumberTRB29-LRG
Device Lot NumberXH31
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/16/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/31/2019
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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