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

Model Number	CTP027015U
Medical Device Problem Codes	Peeled/Delaminated (1454); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the malfunction was provided and a lot history review was performed.The device was returned for evaluation and the investigation is confirmed for peeled material and inconclusive for failure to advance issue.The definitive root cause is unknown.The device is labeled for single use.(pro code: krd).
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model ctp027015u arterial embolization device allegedly experienced peeled/delaminated material and failure to advance.The information was received from a single source.The malfunction involved a patient with no reported patient injury.The patient's age, weight, and gender were not provided.

• 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: 10763147
• Report Number: 9616666-2020-00105
• Device Sequence Number: 11783979
• Product Code: KRD
• UDI-Device Identifier: 00801741155307
• UDI-Public: (01)00801741155307
• 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): 10/30/2020

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: CTP027015U
• Device Catalogue Number: CTP027015U
• Device Lot Number: CMEN0288
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/30/2020
• Patient Sequence Number: 1