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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT ABBOTT ARMADA 35

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ABBOTT ABBOTT ARMADA 35 Back to Search Results
Catalog Number B1070-060
Device Problems Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problems Hemorrhage/Bleeding (1888); Claudication (2550); Pseudoaneurysm (2605)
Event Date 01/05/2016
Event Type  Injury  
Event Description

The armada 35 pta came apart in two separate pieces inside the patient during surgery. The patient presented with peripheral vascular disease with left lower extremity claudication. Left common iliac artery stent, left external iliac artery stent during post inflation the balloon ruptured. At time of post-inflation of the armada 35 pta catheter the balloon ruptured. When attempting to remove the balloon it came out with a separation of the balloon material and the distal portion could not be retrieved through the catheter. Attempted to remove the catheter and just remove it over a wire, but it did not conform to this and could not come through the diseased common femoral artery. Attempts to upside to a larger 7 sheath but that could not be advanced. The patient was bleeding from the groin and developed a pseudoaneurysm. Patient was then put to sleep, and surgeon made an incision to expose the diseased common femoral artery. Placed a vessel loop around this and then created a small arteriotomy in order to retrieve the fragments of the residual balloon that was left in vivo. Once it was removed and examined it was felt to be intact.

 
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Brand NameABBOTT
Type of DeviceARMADA 35
Manufacturer (Section D)
ABBOTT
abbott park IL
MDR Report Key5416213
MDR Text Key37726402
Report Number5416213
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation RISK MANAGER
Type of Report Initial
Report Date 01/11/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received01/12/2016
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/01/2018
Device Catalogue NumberB1070-060
Device LOT Number50521G1
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
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: 01/12/2016 Patient Sequence Number: 1
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