MAUDE Adverse Event Report: ClearStream Technologies Ltd. Halo One Thin-Walled Guiding Sheath

Catalog Number	HLO41018FH
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2026
Type of Reportable Event	Malfunction

• Brand Name: Halo One Thin-Walled Guiding Sheath
• Common Device Name: Guiding 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: michael gaffney ; 800 w. rio salado pkwy; tempe, AZ 85281 ; +1(480)303-2689
• MDR Report Key: 50050286
• Report Number: 9616666-2026-00180
• Device Sequence Number: 9490926
• Product Code: DYB
• UDI-Device Identifier: 00801741184802
• UDI-Public: (01)00801741184802(11)240513(17)270430(10)CMJS0119
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: HLO41018FH
• Device Lot Number: CMJS0119
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2026
• Supplement Date Received by Manufacturer: 08/24/2026
• Initial Report FDA Received Date: 07/28/2026
• Supplement Report FDA Received Date: 08/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/13/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown