• 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 RADIFOCUS INTRODUCER II KIT 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 RADIFOCUS INTRODUCER II KIT INTRODUCER, CATHETER Back to Search Results
Model Number N/A
Device Problem Kinked (1339)
Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Event Date 03/06/2018
Event Type  malfunction  
Manufacturer Narrative
Device was not implanted; device was not explanted. 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. For this reason, evaluation code has been referenced in the conclusions section. Conducted with no findings.
 
Event Description
The user facility reported that the 5 fr. Pinnacle sheath kinked in an artery during a left heart cath. It was a single stick. The entry angle was steeper than 45%, which probably contributed to the kink. The physician had difficulty advancing and torqueing the catheters. The sheath was switched out for an unkinked sheath and the procedure was completed successfully with no injury to patient. Additional information was received on 3/7/18: it was reported that there was a minimal blood loss when getting access.
 
Manufacturer Narrative
This report is being submitted as follow up no. 1 to provide the completed investigation results. The evaluation of the actual device could not be conducted due to the device not being returned.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRADIFOCUS INTRODUCER II KIT
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
terry callahan
950 elkton blvd.
elkton, MD 21921
8002837866
MDR Report Key7369827
MDR Text Key103795044
Report Number1118880-2018-00018
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00389701007243
UDI-Public00389701007243
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K954234
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 03/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2020
Device Model NumberN/A
Device Catalogue NumberRSS501
Device Lot NumberVM25
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/11/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-