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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number B1080-080
Device Problems Migration or Expulsion of Device (1395); Material Rupture (1546); Separation Problem (4043)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 07/10/2019
Event Type  malfunction  
Event Description
During an interventional radiology procedure, right arm fistulogram, the balloon catheter ruptured and while attempting to withdraw the catheter from the body, the marker tip separated from the catheter in the subclavian artery. The catheter marker tip migrated to pulmonary artery. The dr attempted multiple times to snare the marker tip and was successful. The dr ended the case and send pt to ct for further evaluation. Fda safety report id# (b)(4).
 
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Brand NameARMADA 35 PTA CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR
diegem
BE
MDR Report Key8807940
MDR Text Key151743183
Report NumberMW5088250
Device Sequence Number1
Product Code LIT
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/16/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-080
Device Catalogue NumberB1080-080
Device Lot Number90314G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Is This a Reprocessed and Reused Single-Use Device? No

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