MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CHARGER; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

Model Number	24681
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that balloon rupture occurred.A 12.0 x40, 75cm charger balloon catheter was selected for a subclavian angioplasty procedure.During preparation, saline was put into the balloon and upon checking the balloon, a pin hole was noticed.The procedure was completed with another of same device.There were no patient complications and the patient's status was fine.

• Brand Name: CHARGER
• Common Device Name: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9336205
• Report Number: 2134265-2019-13968
• Device Sequence Number: 2244095
• Product Code: FGE
• UDI-Device Identifier: 08714729803867
• UDI-Public: 08714729803867
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112697
• 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): 11/18/2019

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 Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0024259439
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 11/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1