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 4 x 100 sterling balloon catheter was used and completed the case.There were no patient complications reported.

• 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: 10606739
• Report Number: 2134265-2020-13527
• Device Sequence Number: 16844781
• Product Code: PNO
• UDI-Device Identifier: 08714729819752
• UDI-Public: 08714729819752
• 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
• Report Date (Section B): 09/30/2020

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: 10/02/2022
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0024534379
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1