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	09/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon ruptured.The 9% stenosed target lesion was located in the mildly tortuous and highly calcified tibial artery.A 3.50mm/1.5cm/140cm and a 3.00mm/1.5cm/140cm small peripheral cutting balloon were selected for use.During procedure, it was noted that the balloons ruptured and were removed normally off the wire.A 4x100 sterling balloon catheter was used and completed the case.There were no patient complications reported.
Event or Problem Description
It was reported that the balloon ruptured.The 9% stenosed target lesion was located in the mildly tortuous and highly calcified tibial artery.A 3.50mm/1.5cm/140cm and a 3.00mm/1.5cm/140cm small peripheral cutting balloon were selected for use.During procedure, it was noted that the balloons ruptured and were removed normally off the wire.A 4x100 sterling balloon catheter was used and completed the case.There were no patient complications reported.It was further reported that the stenosis was at 90%.

• 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: 10606735
• Report Number: 2134265-2020-13530
• Device Sequence Number: 2941291
• Product Code: PNO
• UDI-Device Identifier: 08714729819745
• UDI-Public: 08714729819745
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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): 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: Health Professional
• Device Expiration Date: 02/16/2023
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0025217538
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/05/2020
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 10/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1