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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 HLO42535H
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/22/2021
Event Type  malfunction  
Event Description
It was reported that prior to the procedure, the foreign material was allegedly found on the tip of the sheath. The procedure was completed by using another device. 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. The investigation of the reported event is currently underway. (expiry date: 10/2022). Device pending return.
 
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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 Key13023671
MDR Text Key282401581
Report Number9616666-2021-00233
Device Sequence Number1
Product Code DYB
UDI-Device Identifier00801741184826
UDI-Public(01)00801741184826
Combination Product (y/n)N
Reporter Country CodeJA
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 02/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLO42535H
Device Catalogue NumberHLO42535H
Device Lot NumberCMEY0645
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/26/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/15/2022
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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