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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. ARMADA CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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ABBOTT VASCULAR INC. ARMADA CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number B1100-040
Device Problems Break (1069); Difficult to Remove (1528); Stretched (1601)
Patient Problem Stenosis (2263)
Event Date 03/02/2022
Event Type  malfunction  
Event Description
A venogram of the bilateral upper extremities to assess for stenosis. The left brachial vein was accessed under ultrasound guidance. The venogram demonstrated multiple stenosis in the left subclavian vein. Balloon angioplasty was performed with 6mm, 8mm, and 10mm balloons. After 2 inflations with the 10mm balloon, the balloon ruptured, and contrast was noted in the subclavian vein. Under fluoroscopic guidance, the balloon catheter was pulled back into the sheath and resistance was noted. Under steady pressure the catheter was withdrawn from the sheath, but resistance was again noted when the balloon catheter was out of the sheath. At this point, the sheath and balloon were withdrawn from the left brachial vein and skin. Additional resistance was noted. Assessment at this point was that the balloon catheter was stretched and sheared with near separation of the balloon portion of the catheter with a portion external to the left arm and a portion that was likely intravascular in the left brachial vein. The proximal portion of the balloon catheter and sheath were removed over a wire. At this point, consult with vascular surgery was obtained. A small cut-down to the left brachial vein to extract the foreign body was performed.
 
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Brand NameARMADA
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez road
temecula CA 92591
MDR Report Key13884978
MDR Text Key287797386
Report Number13884978
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/19/2022,03/09/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/24/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1100-040
Device Catalogue NumberB1100-040
Device Lot Number10903G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/19/2022
Event Location Hospital
Date Report to Manufacturer03/24/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 03/24/2022 Patient Sequence Number: 1
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