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

Model Number 425-2008X

Device Problems Break (1069); Device-Device Incompatibility (2919); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 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
• Type of Device: PTA DILATATION CATHETER
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer (Section G): CLEARSTREAM TECHNOLOGIES LTD.; moyne upper; enniscorthy, co. wexford ; EI
• Manufacturer Contact: judith ludwig ; 1625 w 3rd st.; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 8783094
• MDR Text Key: 151024571
• Report Number: 9616666-2019-00074
• Device Sequence Number: 1
• Product Code: LIT
• UDI-Device Identifier: 00801741132247
• UDI-Public: (01)00801741132247
• 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: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 425-2008X
• Device Catalogue Number: 425-2008X
• Device Lot Number: 50140340
• Date Manufacturer Received: 06/30/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1