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

Model Number	426-2015X
Medical Device Problem Codes	Material Rupture (1546); Stretched (1601)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of reported information indicated that model 426-2015x, pta balloon dilatation catheter, allegedly experienced a rupture and stretched material.This information was received from a single source.This malfunction involved a patient with no consequences.The patient's age, weight, and gender were not provided.

• Brand Name: SLEEK OTW 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: 9183031
• Report Number: 9616666-2019-00123
• Device Sequence Number: 11411063
• Product Code: LIT
• UDI-Device Identifier: 00801741133619
• UDI-Public: (01)00801741133619
• 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): 10/11/2019

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: 426-2015X
• Device Catalogue Number: 426-2015X
• Device Lot Number: 50131974
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 10/12/2019
• Patient Sequence Number: 1