MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK RX PTA CATHETER; PTA BALLOON DILATATION CATHETER

Model Number	425-2012X
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was provided and a lot history review was performed.The sample was returned and the investigation confirmed for the reported failure to cross lesion issue and material deformation.The definitive root cause could not be determined.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 425-2012x pta balloon dilatation catheter allegedly experienced failure to advance and material deformation.This information was received from one source.One patient was involved with no reported patient injury.The patient age, weight, and gender was not provided.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA BALLOON DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• MDR Report Key: 9211410
• Report Number: 9616666-2019-00129
• Device Sequence Number: 19492889
• Product Code: LIT
• UDI-Device Identifier: 00801741132261
• UDI-Public: (01)00801741132261
• 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): 10/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 425-2012X
• Device Catalogue Number: 425-2012X
• Device Lot Number: 50145796
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/18/2019
• Patient Sequence Number: 1