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

Model Number 425-2522X

Device Problems Material Deformation (2976); Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a lot history review was performed.The sample was returned to the manufacturer for inspection/evaluation.Therefore, the investigation is confirmed for the reported material twist/bent and material deformation.Based on the available information, the definitive root cause for this event is unknown.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicates that model 425-2522x pta dilatation catheter allegedly material twisted/bent and material deformed.The information was received from a single source.The malfunction did not involve a patient with no known impact to the patient.The patients' age, weight and gender were not provided.

• Brand Name: SLEEK RX PTA CATHETER
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford N A ; EI N A
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 10714693
• MDR Text Key: 214800711
• Report Number: 9616666-2020-00093
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132407
• UDI-Public: (01)00801741132407
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 425-2522X
• Device Catalogue Number: 425-2522X
• Device Lot Number: CMDX0221
• Date Manufacturer Received: 09/30/2020
• Type of Device Usage: N
• Patient Sequence Number: 1