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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 Problems Deflation Problem (1149); Activation, Positioning or SeparationProblem (2906)
Patient Problems Hematoma (1884); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/22/2021
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. The actual device has not been returned for evaluation. The investigation is currently ongoing. A follow up report will be submitted once the investigation is complete. (b)(4). A review of the device history record of the product code/lot# combination was conducted with no findings.
 
Event Description
The user facility reported that patient was treated for a tavi placement through the right femoral route, during arterial closure, there was a malfunction of the angio-seal device. The issues were during deployment. Realization of a manual compression. Not of consequence but there was a risk of hemorrhage.
 
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Brand NameTR BAND
Type of DeviceCLAMP, VASCULAR
Manufacturer (Section D)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
suite 320
elkton MD 21921
Manufacturer (Section G)
TERUMO MEDICAL CORPORATION
950 elkton blvd.
caguas west industrial park
elkton MD 21921
Manufacturer Contact
mary o'neill
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key11410552
MDR Text Key234623327
Report Number0001118880-2021-00074
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K152525
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/04/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Device Lot Number0000023628
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/02/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/12/2020
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: 03/04/2021 Patient Sequence Number: 1
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