MAUDE Adverse Event Report: BARD PERIPHERAL VASCUTRAK PTA DILATATION CATHETER; BALLOON CATHETER

Catalog Number V1850150

Device Problem Deflation Problem (1149)

Patient Problem Unknown (for use when the patient's condition is not known) (2202)

Event Date 12/04/2014

Event Type  Injury  

Event Description

During a cath procedure (right lower extremity angiogram, the physician was unable to deflate the balloon to the right superfemoral artery.Guided by fluoroscopy, the physician took a small needle through the leg and popped the balloon so he could remove the balloon.

• Brand Name: VASCUTRAK PTA DILATATION CATHETER
• Type of Device: BALLOON CATHETER
• Manufacturer (Section D): BARD PERIPHERAL; 1625 west 3rd st.; tempe AZ 85281
• MDR Report Key: 4471127
• MDR Text Key: 15817762
• Report Number: 4471127
• 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: Nurse
• Type of Report: Initial
• Report Date: 12/05/2014,12/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: V1850150
• Device Lot Number: GFYH0032
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/16/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR