MAUDE Adverse Event Report: ABBOTT VASCULAR AMADA 18 PTA CATHETER CATHETER ANGIOPLASTY, PERIPHERAL

Model Number AMANDA 18

Device Problem Positioning Problem (3009)

Patient Problem Perforation (2001)

Event Date 10/22/2018

Event Type  Injury  

Event Description

A balloon was used intra op (abbott vascular armada 5 mm x 100 mm; 150 cm, ref# (b)(4), lot # 7040541, manufacture date: 04/05/2017, exp 09/30/2020) which perforated the blood vessel.

• Brand Name: AMADA 18 PTA CATHETER
• Type of Device: CATHETER ANGIOPLASTY, PERIPHERAL
• Manufacturer (Section D): ABBOTT VASCULAR; santa clara CA 95054
• MDR Report Key: 8248399
• MDR Text Key: 133375625
• Report Number: MW5083079
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: AMANDA 18
• Device Catalogue Number: 1013468-100
• Device Lot Number: 7040541
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 01/11/2019 Patient Sequence Number: 1