MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. CATERPILLAR EMBOLIZATION SYSTEM; ARTERIAL EMBOLIZATION DEVICE

Model Number	CTP038020U
Medical Device Problem Code	Poor Quality Image (1408)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a lot history review was performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation was inconclusive for the reported device visualization issue.Based upon the available information, the definitive root cause for this malfunction was unknown.The device was labeled for single use.(pro code: krd).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model ctp038020u arterial embolization device alleged difficult/unable to be visualized under fluoroscopy.This information was received from one source.The malfunction involved patient with no known impact to the patient.The male patient was (b)(6) years old and weighed (b)(6).

• Brand Name: CATERPILLAR EMBOLIZATION SYSTEM
• Common Device Name: ARTERIAL EMBOLIZATION DEVICE
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 10726996
• Report Number: 9616666-2020-00100
• Device Sequence Number: 14514670
• Product Code: KRD
• UDI-Device Identifier: 00801741155314
• UDI-Public: (01)00801741155314
• 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): 10/23/2020

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: CTP038020U
• Device Catalogue Number: CTP038020U
• Device Lot Number: CMDX0438
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/23/2020
• Patient Sequence Number: 1