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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ABBOTT ARMADA 35 7.0X40 MM BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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ABBOTT VASCULAR ABBOTT ARMADA 35 7.0X40 MM BALLOON CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Lot Number 11206G1
Device Problem Material Rupture (1546)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 03/17/2022
Event Type  malfunction  
Event Description
A 7 x 40 balloon was placed into right iliac artery to open up stenosis, and when the balloon was inflated it ruptured. The surgeon then had to make a larger opening to be able to remove the remains of the balloon. They were unable to use a closure device due to the size of the opening. They then held pressure for 20 mins then placed a dressing on the access site and took the patient to recovery. Once in recovery the patient began to bleed more and was taken back to the operating room. They were able to hold pressure for additional time to get the bleeding to stop and did not have to do a cut down. The patient was then taken back to recovery. Fda safety report id # (b)(4).
 
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Brand NameABBOTT ARMADA 35 7.0X40 MM BALLOON
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
ABBOTT VASCULAR
MDR Report Key14074599
MDR Text Key289092293
Report NumberMW5108874
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 Risk Manager
Type of Report Initial
Report Date 04/06/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Lot Number11206G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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