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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA TR BAND VASCULAR CLAMP

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TERUMO CORPORATION, ASHITAKA TR BAND VASCULAR CLAMP Back to Search Results
Catalog Number XX-RF06
Device Problems Air Leak (1008); Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 03/10/2017
Event Type  malfunction  
Manufacturer Narrative
Udi no. - not required to be registered with the fda. The actual device was returned to the manufacturing facility for evaluation. Visual inspection found that the air injection tube had been fractured. The air injection tube was measured and found to have been stretched. Magnifying inspection of the lateral side of the air injection tube around the fracture confirmed no anomalies. Magnifying inspection of the fracture cross-section of the air injection tube revealed a stripe-like pattern crossing the surface from the outside circumference to the inside circumference. Electron microscopic inspection of the fracture cross-section of the air injection tube found several stripe-like patterns on the surface as well as several clearer stripes crossing the surface from the outside circumference to the inside circumference. The outside diameter of the air injection tube was found to be thinner along the total length of the tube than that of the current sample from the involved product code. Simulation testing was conducted on a sample from the involved product code. The air injection tube of the sample was exposed to a pulling force until it became fractured. Magnifying microscopic inspection of the fracture cross-section of the air injection tube found several stripe-like patterns had been generated on the surface with several stripes crossing the surface from the outside circumference to the inside circumference. The total length of the tube was measured and found to have been stretched. The state of the sample was found to be similar to that of the actual sample. A review of the device history record and the product release decision control sheet of the product code/lot combination was conducted with no relevant findings. A search of the complaint file find no other report with the involved product code/lot number combination of this nature. There is no evidence that this event was related to a device defect or malfunction. While the exact cause of the reported event cannot be definitively determined based on the available information, it is likely the air injection tube of the actual device was subjected to an excessive pulling force, resulting in the reported fracture. (b)(4). All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending and follow-up.
 
Event Description
The user facility reported a tube fracture on the tr band device during a procedure. Follow up communication with the user facility confirmed the following information: the patient was taken to the ward with the actual sample applied to the wrist; when the nurse checked, while the patient stayed on rest, it was noted that the air injection tube of the actual sample had been fractured and the balloons had been deflated; there was some bleeding from the patient's access site, an exact amount was not reported; hemostasis treatment was conducted on the patient in the ward; and the patient was not harmed.
 
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Brand NameTR BAND
Type of DeviceVASCULAR CLAMP
Manufacturer (Section D)
TERUMO CORPORATION, ASHITAKA
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer (Section G)
TERUMO CORPORATION, ASHITAKA
reg. no. 9681834
150 maimaigi-cho
fujinomiya city, shizuoka 418
JA 418
Manufacturer Contact
jennifer suh
reg. no. 2243441
2101 cottontail ln.
somerset, NJ 08873
8002837866
MDR Report Key6491012
MDR Text Key72795847
Report Number9681834-2017-00067
Device Sequence Number1
Product Code DXC
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K070423
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 04/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2018
Device Catalogue NumberXX-RF06
Device Lot Number160601
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/17/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/15/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
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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