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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 Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/12/2019
Event Type  malfunction  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. One used large tr band assembly was returned for product evaluation. The inflator was not returned for product evaluation. Visual inspection revealed that the balloons were tried to be separated and as the result of this separation, the communication port which welds the small and large balloon together was torn. Leak testing was not able to be performed since the communication port is ruptured. A review of the device history record of the product code/lot# combination was conducted with no findings. Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction. Based on the investigation results it is likely that the balloons were attempted to be separated prior to inflating which could have caused the rip in the communication port. However, the exact cause of the reported event cannot be definitively determined based on the available information.
 
Event Description
The user facility reported that the tr band plastic was stuck together, and they felt that the balloon bladder was compromised. They pulled a different tr band to use and it did not have an issue. The patient condition was fine, and hemostasis was achieved with the second tr band. The procedure outcome was successful. Additional information was received on 30jul2019. The first tr band was not used on the patient.
 
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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 Key10154726
MDR Text Key200046212
Report Number1118880-2020-00158
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 06/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Model NumberN/A
Device Catalogue NumberTRB29-LRG
Device Lot NumberXC25
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/06/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/25/2019
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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