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

Model Number HLO54535

Device Problems Device Contamination with Chemical or Other Material (2944); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/02/2021

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.

Event Description

It was reported that during preparation for an angioplasty procedure, the tip of the sheath was allegedly rough and foreign substance like white powder adhered to the device. The procedure was completed by using another device. There was no patient contact.

• Brand Name: HALO ONE THIN-WALLED GUIDING SHEATH
• Type of Device: 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12880707
• Report Number: 9616666-2021-00207
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741161926
• UDI-Public: (01)00801741161926
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K192313
• Number of Events Reported: 1
• 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: 01/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: HLO54535
• Device Catalogue Number: HLO54535
• Device Lot Number: CMEX0527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Age: 80 YR
• Patient Sex: Male
• Patient Weight: 60 KG