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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR AMADA 18 PTA CATHETER CATHETER ANGIOPLASTY, PERIPHERAL Back to Search Results
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.
 
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Brand NameAMADA 18 PTA CATHETER
Type of DeviceCATHETER ANGIOPLASTY, PERIPHERAL
Manufacturer (Section D)
ABBOTT VASCULAR
santa clara CA 95054
MDR Report Key8248399
MDR Text Key133375625
Report NumberMW5083079
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
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 Received01/11/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2020
Device Model NumberAMANDA 18
Device Catalogue Number1013468-100
Device Lot Number7040541
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
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