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

Model Number	426-1201X
Medical Device Problem Codes	Material Rupture (1546); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the reported malfunction was provided, therefore, a lot history review was performed.The device was returned to the manufacturer for evaluation.Therefore, the investigation is confirmed for the reported balloon rupture, and material deformation.The root cause could not be determined based upon the available information.The device is labeled for singe use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 426-1201x pta balloon dilatation catheter allegedly experienced material rupture and material deformation.The information was received from a single source.One patient was involved with no reported patient injury.The patient age, weight and gender was 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: 10718986
• Report Number: 9616666-2020-00099
• Device Sequence Number: 1138953
• Product Code: DQY
• UDI-Device Identifier: 00801741133497
• UDI-Public: (01)00801741133497
• 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): 10/22/2020

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: 426-1201X
• Device Catalogue Number: 426-1201X
• Device Lot Number: CMCX0472
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/22/2020
• Patient Sequence Number: 1