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

Catalog Number	HLO47035
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On(b)(6) 2026, a patient underwent recanalization procedure using a halo one device.It was reported that before use the hemostatic valve cannot be screwed onto the sheath.There was no patient contact.
Additional Manufacturer Narrative
H11: 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.Section a through f: the information provide by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• 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: 50895115
• Report Number: 9616666-2026-00233
• Device Sequence Number: 10711680
• Product Code: DYB
• UDI-Device Identifier: 00801741161858
• UDI-Public: (01)00801741161858(17)270731(10)CMJV0136
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K192313
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/08/2026

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: HLO47035
• Device Lot Number: CMJV0136
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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