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

Model Number	HLO51035F
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, a manufacturing review was performed.The sample was not returned to the manufacturer for evaluation.The investigation was inconclusive for the reported dilator break and split issues.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model hlo51035f thin-walled guiding sheath allegedly experienced sheath dilator broke and the distal tip split.This information was received from one source.This malfunction involved a patient with no known impact to the patient.The patient's age, sex and weight were unknown.

• 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
• MDR Report Key: 10284147
• Report Number: 9616666-2020-00073
• Device Sequence Number: 689378
• Product Code: DYB
• UDI-Device Identifier: 10801741161909
• UDI-Public: (01)10801741161909
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/16/2020

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: No Information
• Device Model Number: HLO51035F
• Device Catalogue Number: HLO51035F
• Device Lot Number: CMEQ0640
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2020
• Initial Report FDA Received Date: 07/16/2020
• Patient Sequence Number: 1