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	Embolism (1829)
Date of Event	11/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that balloon rupture and embolization occurred.The target lesion was located in the superior femoral artery.A 6.0 x100, 135cm charger balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured and left an embolus behind.No known further patient complications were reported.
Event or Problem Description
It was reported that balloon rupture and embolization occurred.The target lesion was located in the superior femoral artery.A 6.0 x100, 135cm charger balloon catheter was advanced for dilatation.However, upon inflation, the balloon ruptured and left an embolus behind.No known further patient complications were reported.It was further reported that contrast was observed after the balloon ruptured and no part of the balloon was left inside the patient's body.

• 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: 9490436
• Report Number: 2134265-2019-15918
• Device Sequence Number: 19217880
• Product Code: FGE
• UDI-Device Identifier: 08714729804291
• UDI-Public: 08714729804291
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/04/2022
• Device Model Number: 24681
• Device Catalogue Number: 24681
• Device Lot Number: 0024380446
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/11/2019
• Supplement Date Received by Manufacturer: 01/09/2020
• Initial Report FDA Received Date: 12/18/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other