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); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One device was returned for evaluation.The lot history review was performed.The investigation confirmed for material rupture, material deformation, and stretched.A root cause has not been determined.The device is labeled for single use.
Event or Problem Description
This report summarizes one malfunction.The information reviewed indicated that model 426-2015x pta balloon dilatation catheter allegedly experienced rupture, stretched material, and material deformation.This report was received from one source.The patient's age, weight, and gender were not provided.There was no reported patient injury.

• 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: 9183012
• Report Number: 9616666-2019-00121
• Device Sequence Number: 19481024
• Product Code: DQY
• 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: 50139792
• 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