MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SMALL PERIPHERAL CUTTING BALLOON; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24642
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in the lower extremity popliteal artery.During the procedure, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient was fine.
Event or Problem Description
It was reported that a balloon rupture occurred.A 4.00mm/1.5cm/140cm small peripheral cutting balloon was selected for use in the lower extremity popliteal artery.During the procedure, the balloon ruptured.The procedure was completed with a different device.No patient complications were reported and the patient was fine.It was further reported that the balloon ruptured at first inflation.

• Brand Name: SMALL PERIPHERAL CUTTING BALLOON
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8519107
• Report Number: 2134265-2019-03939
• Device Sequence Number: 1501666
• Product Code: PNO
• UDI-Device Identifier: 08714729819769
• UDI-Public: 08714729819769
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070951
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2019

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: Health Professional
• Device Expiration Date: 01/28/2022
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0023262540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/27/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 04/16/2019
• Supplement Report FDA Received Date: 05/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1