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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number 1013464-200
Device Problems Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Foreign Body In Patient (2687)
Event Date 03/21/2022
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the superficial femoral artery. The device was flushed while inside the hoop. The 2. 5mm x 200mm x 150cm armada 18 balloon dilatation catheter (bdc) was advanced to the target lesion without issue. During the second inflation to 18 atmospheres the balloon ruptured. The bdc was removed without resistance and after removal it was observed that the proximal balloon marker had detached from the bdc and was located in the perineal artery. No attempt was made to retrieve the proximal balloon marker. There was no clinically significant delay during the procedure. No additional information was provided.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key14004057
MDR Text Key288596013
Report Number2024168-2022-03547
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1013464-200
Device Catalogue Number1013464-200
Device Lot Number1041641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/16/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 04/04/2022 Patient Sequence Number: 1
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