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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 Use of Device Problem (1670)
Patient Problems Pain (1994); Pallor (2468)
Event Date 12/07/2021
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacture date: unknown due to unknown lot number. 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. The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record.
 
Event Description
The user facility reported that the treating physician injected air from the tr band inflator into the sheath hub instead of the tr band inflation balloon. When air was injected into the sheath hub the patient became transiently ill, then made a full recovery. The procedure was successful, and the patient was stable. Additional information received on 14december2021: the type of procedure being performed was a neurovascular embolization. The amount of air injected into the sheath hub was 18 milliliters. The sheath was immediately aspirated with removal of a small amount of air. The patient soon became pale with diminished responsiveness that lasted for approximately two minutes. There was no change in blood pressure or oxygen saturation, although a small increase in end tidal carbon dioxide was noted. The patient gradually became more responsive without focal deficit and within a relatively short time had returned to baseline neurologic function. The arterial sheath was removed. The patient noted mild pain in the right hand that soon resolved. Hemostasis was successfully achieved.
 
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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
mary o'neill
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key13119509
MDR Text Key285613139
Report Number1118880-2021-00220
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 Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberTRB24-REG
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/07/2022
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: 12/30/2021 Patient Sequence Number: 1
Treatment
GLIDESHEATH SLENDER
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