MAUDE Adverse Event Report: COVIDIAN EVERCROSS 0.035 6X200 PTA BALLOON CATHETER; BALLOON CATHETER, AB35W06200135

Lot Number A077972

Device Problems Balloon rupture (1049); Balloon burst (1051)

Patient Problem Perforation of Vessels (2135)

Event Date 04/16/2015

Event Type  Injury  

Event Description

During a femoral angioplasty and stent placement to the pt's right femoral artery, the balloon ruptured and came off of the shaft.The physician used a snare to capture the balloon.Another balloon catheter was used.A small perforation to the right femoral artery was noted and a viabahn stent was used to cover the area.Good blood flow noted in vessel after stent placed.

• Brand Name: EVERCROSS 0.035 6X200 PTA BALLOON CATHETER
• Type of Device: BALLOON CATHETER, AB35W06200135
• Manufacturer (Section D): COVIDIAN; 3033 campus drive; plymouth MN 55441
• MDR Report Key: 4812537
• MDR Text Key: 5916238
• Report Number: 4812537
• Device Sequence Number: 1
• Product Code: LIT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/22/2018
• Device Lot Number: A077972
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/20/2015
• Event Location: Other
• Date Report to Manufacturer: 04/23/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR