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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 Gas Leak (2946)
Patient Problems Hematoma (1884); No Code Available (3191)
Event Date 08/29/2018
Event Type  Injury  
Manufacturer Narrative
Device was not implanted. The actual device has been 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
The user facility reported that the tr band device leaked air. Post cardiac cath, the patient had a size regular tr band placed and after the patient's band was in place, air decreased on it's own creating a hematoma on the patients wrist post procedure and while the patient was in recovery. A staff member reported this happened once with the physician placing the band and once with a tech placing the band. A 15cc was injected initially and then they followed the protocol of removing air until a flash of blood and adding 2cc into the band and everything was fine with the band when the patient left. It was reported that over time the balloon lost air prior to them releasing any. The patient experienced a hematoma. The patient condition is stable. The staff had to hold pressure to evacuate the hematoma. Additional information was received on 9/4/18. The radial procedure itself was successful, the hematoma occurred post procedure.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to update and provide the completed investigation results. One tr band regular assembly was returned for evaluation. The tr band regular assembly was returned with the tr band inflator. Visual inspection revealed no gross anomalies. The returned inflator was then used to inflate the tr band regular assembly. After the balloon assembly was inflated, the assembly lost air rapidly. The assembly was then inflated and submerged underwater. A rapid trail of bubbles formed from the air inlet valve. Once the inlet valve was sealed no other leaks were detected in the assembly. Microscopic and fluoroscopic images of the air inlet port revealed no anomalies. The valve was then deconstructed and a fiber was found on the plastic plug in the air inlet port. Terumo has determined the reported event to be manufacturing related and is being further investigated.
 
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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
mark vornheder
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key7863730
MDR Text Key119788624
Report Number1118880-2018-00114
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 09/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Device Lot NumberWC22
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2018
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: 09/11/2018 Patient Sequence Number: 1
Treatment
GLIDESHEATH SLENDER
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