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

Model Number	24642
Medical Device Problem Codes	Inflation Problem (1310); Difficult to Remove (1528)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the balloon has removal difficulty.The 99% tightly stenosed target lesion was located in a severely calcified distal posterior tibial artery.A 2.00mm /1.5cm/ 140cm small peripheral cutting balloon was selected for use.During the procedure, two attempts were made to inflate the balloon; however the balloon did not inflate and started filling through the wire port instead of into the balloon.Removal difficulty was noted when withdrawing the device from the patient's body.It was further reported that the balloon was slowly withdrawn over the wire, and pulling the wire back.There was no intervention done to remove the balloon from the patient's body.The procedure was completed with another balloon.No patient complications were reported.Patient was good post procedure with no adverse outcome.

• 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: 9117611
• Report Number: 2134265-2019-11582
• Device Sequence Number: 2347062
• Product Code: PNO
• UDI-Device Identifier: 08714729819721
• UDI-Public: 08714729819721
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Report Date (Section B): 09/25/2019

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: 01/17/2020
• Device Model Number: 24642
• Device Catalogue Number: 24642
• Device Lot Number: 0020171372
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2019
• Initial Report FDA Received Date: 09/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1