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U.S. Department of Health and Human Services

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

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CLEARSTREAM TECHNOLOGIES LTD. HALO ONE GUIDING SHEATH Back to Search Results
Model Number HLO61035
Device Problems Difficult to Insert (1316); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/27/2022
Event Type  malfunction  
Event Description
It was reported that during an angioplasty procedure, there was resistance felt and the sheath was allegedly unable to be inserted. Reportedly, the tip of the dilator was allegedly found peeled and torn after removing from patient. The procedure was completed using another device. There was no reported patient injury.
 
Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records was performed. The sample was not returned to the manufacturer for inspection/evaluation. Therefore, the investigation of the reported event is inconclusive. Based upon the available information, the definitive root cause for this event is unknown. The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device. Upon receipt of new or additional information, a follow-up report will be submitted as applicable. Expiry date: 12/2023.
 
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Brand NameHALO ONE
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
brett curtice
800 w. rio salado pkwy
tempe, AZ 85281
4803032689
MDR Report Key15090247
MDR Text Key298301312
Report Number9616666-2022-00156
Device Sequence Number1
Product Code DYB
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
Report Date 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/23/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberHLO61035
Device Catalogue NumberHLO61035
Device Lot NumberCMGN0486
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/27/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2022
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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