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

Model Number	436-2515X
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicates that model 436-2515x pta balloon dilatation catheter allegedly experienced material deformation, catheter stretched, packaging problem and detachment of device or device component.The information was received from a single source.This malfunction did not involve a patient as there was no patient contact.The female patient is (b)(6) and weighs (b)(6).

• Brand Name: SAVVY LONG 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: 10715262
• Report Number: 9616666-2020-00097
• Device Sequence Number: 11500496
• Product Code: LIT
• UDI-Device Identifier: 00801741132827
• UDI-Public: (01)00801741132827
• 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): 10/21/2020

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: 436-2515X
• Device Catalogue Number: 436-2515X
• Device Lot Number: CMDS0495
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2020
• Initial Report FDA Received Date: 10/21/2020
• Patient Sequence Number: 1