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

Model Number	425-2008X
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the reported information, the device was returned to bd and evaluated.The result of the investigation is confirmed for the break issue reported.There was a break noted in the shaft 210mm from the strain relief.There was a also a kink noted 15mm from the break and a number of bends along the length of the shaft.The method of packaging may have contributed to these bends and the kink.The definitive root cause for the reported break issue could not be determined based upon available information.The device is labeled for single use.
Event or Problem Description
This report summarizes one (1) malfunction.A review of the reported information indicated that model 425-2008x pta dilatation catheter allegedly experienced a break, material deformation, and device-device incompatibility.This information was received from one source.The malfunction involved a patient with no known impact to the patient.Patient age, weight, and gender were not provided.

• Brand Name: SLEEK RX PTA CATHETER
• Common Device Name: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• MDR Report Key: 8783094
• Report Number: 9616666-2019-00074
• Device Sequence Number: 1822551
• Product Code: LIT
• UDI-Device Identifier: 00801741132247
• UDI-Public: (01)00801741132247
• 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): 07/11/2019

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: 425-2008X
• Device Catalogue Number: 425-2008X
• Device Lot Number: 50140340
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/11/2019
• Patient Sequence Number: 1