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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER INTRODUCER, CATHETER

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TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Material Deformation (2976)
Patient Problem Ventricular Fibrillation (2130)
Event Date 09/03/2019
Event Type  Injury  
Manufacturer Narrative
Implanted date: device was not implanted. Explanted date: device was not explanted. 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. This report is for the first event reported, for the second event reported with the same device that was used on the same patient see mdr 1118880-2019-00290.
 
Event Description
The user facility reported that while the doctor was performing a left heart catheterization with a tiger catheter, they cannulated the right coronary artery and the tip of the tiger slipped into conus and the patient went into v-fib. The patient was shocked and was moving quite a bit with the tiger catheter exiting the 5fr glidesheath slender. When the doctor tried to pull the tiger out, he noticed that the sheath was accordion. As soon as the tiger was pulled out, the sheath started leaking from between the hub and where the sheath is welded to it. The doctor cut the sheath, rewired distal part of the sheath and replaced to finish the case. The patient was reported to be in stable condition. The procedure outcome was successful. Additional information was received on 11sept19. There was no blood loss. The physician used a cordis femoral sheath because he needed. 035. And then replaced with 6fr glidesheath slender. There was no harm to the patient.
 
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Brand NameGLIDESHEATH SLENDER
Type of DeviceINTRODUCER, CATHETER
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
theresa mussaw
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key9141310
MDR Text Key161740685
Report Number1118880-2019-00262
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173831
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,Followup
Report Date 10/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2021
Device Model NumberN/A
Device Catalogue Number80-1050
Device Lot NumberXD13
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2019
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/14/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/13/2019
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: 10/01/2019 Patient Sequence Number: 1
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