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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 B2100-060
Device Problems Break (1069); Detachment Of Device Component (1104); Material Fragmentation (1261)
Patient Problems Occlusion (1984); Device Embedded In Tissue or Plaque (3165)
Event Date 04/07/2017
Event Type  malfunction  
Event Description
Per rn description: armada 35 pta catheter detached within patient. The balloon was inflated then deflated and when doctor was moving the device out it snapped apart leaving half of the balloon inside the patient. The balloon was able to be removed. Per md: the patient did have an occlusion of the innominate vein with small collaterals filling that region. The decision was made to intervene. We upsized the sheath to a 7-french sheath and crossed the lesion with a berenstein catheter as well as a glidewire. After this was crossed, we then used a 6 x 200 mm armada balloon to balloon the entire region. We then used an 8 x 80 armada balloon without good success and we upsized to a 10 x 60 armada balloon. The armada balloon was taken down, and while withdrawing the armada balloon, the proximal portion of the balloon became disrupted and was only partially removed. The remaining distal portion was still on the wire. We then upsized the sheath to a 10-french sheath and used buddy wire technique to snare the rosen wire and removed the entire apparatus. We then placed pressure over the wound, used 4-0 monocryl to close the subcuticular layer over this and we applied venous pressure for greater than 15 minutes. This was then hemostatic. The balloon was evaluated and all the balloon was removed after the snare technique.
 
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Brand NameARMADA
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR INC.
26531 ynez rd.
temecula CA 92591
MDR Report Key6518995
MDR Text Key73617606
Report Number6518995
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 User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/10/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2017
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2100-060
Device Catalogue NumberB2100-060
Device Lot Number60830G1
Other Device ID NumberARAMDA 35 PTA CATHETER 10 MM
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2017
Event Location Hospital
Date Report to Manufacturer04/10/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/25/2017 Patient Sequence Number: 1
Treatment
7-FRENCH SHEATH, BERENSTEIN CATHETER, GLIDEWIRE; NO OTHER THERAPIES
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