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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
Catalog Number 1014256-080
Device Problems Material Rupture (1546); Material Separation (1562); Difficult to Advance (2920)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/03/2022
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 treat a heavily calcified superficial femoral artery (sfa). During advancement the 5. 0x80mm armada 18 balloon dilatation catheter (bdc) met resistance with anatomy and during the first inflation the balloon ruptured at 10 atmospheres. The bdc was removed from the unspecified sheath; however, it was noted pieces of the balloon were missing. Snaring was attempted to remove the separated pieces but was not successful; therefore, an unknown supera stent was deployed to embed the separated portions into the vessel wall. There was no adverse patient sequela; however, a clinically significant delay was reported. 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 Key13940747
MDR Text Key288127977
Report Number2024168-2022-03276
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/29/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1014256-080
Device Lot Number1120941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/28/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/09/2021
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: 03/29/2022 Patient Sequence Number: 1
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