• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO MEDICAL CORPORATION GLIDESHEATH SLENDER INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Material Too Rigid or Stiff (1544)
Patient Problem Cramp(s) /Muscle Spasm(s) (4521)
Event Date 08/31/2020
Event Type  malfunction  
Manufacturer Narrative
Expiration date - unknown due to unknown product code and lot number. Udi: unknown due to unknown product code and lot number. Implanted date: device was not implanted. Explanted date: device was not explanted. Device manufacturer date - unknown due to unknown product code and lot number. Pma/510(k): unknown due to unknown product code and 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 progreat coaxial. Device malfunction, despite careful advancement of the guidewire, it caused spasm at the radial artery. Additional information was received on 22sept2020. There was only one device used, and caused spasms. The procedure being performed was a uterine fibroid embolization. The procedure was completed through radial access. There was no blood loss. There was no medical intervention required. It should have been the wire in the slender sheath kit, it was stated that it felt too stiff. Additional information was received 24sep2020. The progreat coaxial was not the device that malfunctioned, it should have been the wire in the slender sheath kit. The doctor stated that it felt too stiff which caused spasm in the radial artery. Per the doctor, it was not the progreat that was the issue. He had issues with the nitinol wire that was in the slender kit. He said it felt more stiff than normal and he had to switch to a nitrix wire. There was some spasm; however, nothing that needed the case to get cancelled. The case was performed successfully, and no other issues had happened.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10618768
MDR Text Key209590476
Report Number1118880-2020-00257
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/02/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2022
Device Model NumberN/A
Device Catalogue Number50-1050
Device Lot NumberYC12
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-