MAUDE Adverse Event Report: EV3 EVERCROSS; DILATION CATHETER

Model Number	0.35" OTW PTA
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/02/2016
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient underwent coronary angiography.During the procedure, the patient developed balloon being lodged in the distal aorta at the left iliac artery.Patient required surgery for extraction of the balloon.

• Brand Name: EVERCROSS
• Common Device Name: DILATION CATHETER
• Manufacturer (Section D): EV3; plymouth MN 55442
• MDR Report Key: 6075343
• Report Number: MW5065778
• Device Sequence Number: 19072290
• Product Code: LIT
• UDI-Device Identifier: 00821684062098
• UDI-Public: (01)00821684062098(17)190223(10)
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 11/01/2016

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: 0.35" OTW PTA
• Device Catalogue Number: AB35W08080080
• Device Lot Number: A232691
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/01/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ENTRUST DELIVERY SYSTEM; EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR