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

MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH

  • 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
 

CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH Back to Search Results
Model Number HLO62535
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/26/2022
Event Type  malfunction  
Event Description
It was reported that during preparation for a recanalization procedure, the device luer lock allegedly did not connect tightly and the sheath opened by itself. There was no patient contact.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed. The return of the sample is pending. However, a video was provided for review. The investigation of the reported event is currently underway. (expiration date: 04/2022).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameHALO ONE THIN-WALLED GUIDING SHEATH
Type of DeviceGUIDING SHEATH
Manufacturer (Section D)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer (Section G)
CLEARSTREAM TECHNOLOGIES LTD.
moyne upper
enniscorthy, co. wexford N A
EI N A
Manufacturer Contact
judy ludwig
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key13576935
MDR Text Key286469869
Report Number9616666-2022-00024
Device Sequence Number1
Product Code DYB
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K192313
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/23/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLO62535
Device Catalogue NumberHLO62535
Device Lot NumberCMES0316
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/22/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-