MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES LTD. SLEEK PTA DILATATION CATHETER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	425-2010X
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
As the surgeon was advancing the balloon catheter through the sheath, the catheter completely broke.The balloon catheter was removed in its entirety with no harm to the patient.

• Brand Name: SLEEK PTA DILATATION CATHETER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES LTD.; 1 becton dr; franklin lakes NJ 07417
• MDR Report Key: 8764021
• Report Number: 8764021
• Device Sequence Number: 13850713
• Product Code: LIT
• UDI-Device Identifier: 00801741132254
• UDI-Public: (01)00801741132254
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/26/2019
• Report Date (Section F): 06/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 425-2010X
• Device Catalogue Number: 425-2010X
• Device Lot Number: CMBR0125
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/05/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 67
• Date Report Sent to FDA: 06/26/2019