MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON®; CATHETER, PERCUTANEOUS, CUTTING/SCORING

Model Number	M001PCBO4015140F0
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2017
Type of Reportable Event	Malfunction
Event or Problem Description
We opened an angioplasty cutting balloon.This type of balloon and little blades around it so it comes packaged with a safety sheath covering the balloon.Before placing the balloon on a wire to enter the patient, the sheath is removed.When the endovascular tech removed the sheath, the entire balloon blades and all remained in the sheath and came completely off the catheter.Device did not reach patient.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON®
• Common Device Name: CATHETER, PERCUTANEOUS, CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 6993242
• Report Number: 6993242
• Device Sequence Number: 13776093
• Product Code: PNO
• UDI-Device Identifier: 08714729819769
• UDI-Public: (01)08714729819769
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/06/2017
• Report Date (Section F): 10/06/2017

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 Expiration Date: 02/18/2019
• Device Model Number: M001PCBO4015140F0
• Device Catalogue Number: M001PCBO4015140F0
• Device Lot Number: 18941810
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NO.
• Patient Age: 64 YR
• Date Report Sent to FDA: 10/06/2017