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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. HALO ONE THIN-WALLED GUIDING SHEATH Back to Search Results
Model Number HLO61035F
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/05/2022
Event Type  malfunction  
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. The investigation of the reported event is currently underway. (expiry date: 06/2022).
 
Event Description
It was reported that prior to a procedure to treat stenosis, the luer lock was not possible to connect tightly and the sheath allegedly kept opening by itself. There was no patient contact.
 
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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 Key13442501
MDR Text Key286469588
Report Number9616666-2022-00006
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 03/03/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/03/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLO61035F
Device Catalogue NumberHLO61035F
Device Lot NumberCMEU0493
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2020
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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