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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B1080-040
Device Problems Material Rupture (1546); Material Separation (1562)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 10/01/2020
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. The additional armada device referenced is being filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat an aorta bifurcation. An 8x40mm armada 35 balloon was advanced to the lesion and was inflated 1-2 times at 8 atmospheres (atms) when it ruptured and a piece (around 1 to 2mm length) of balloon released in the artery. Another 8x40mm armada 35 balloon was inflated once and burst at 8 atms. It was decided to attempt to retrieve the balloon portion that separated from the first armada 35 but it wasn't possible. Therefore, a stent was used to embed the separated balloon piece to the vessel wall. The patient was transferred to the intensive care unit afterwards. On day 4, the patients clinical condition was hemodynamically good. There was no adverse patient sequela and no clinically significant delay. No additional information was provided.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key10720627
MDR Text Key212705723
Report Number2024168-2020-08846
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/22/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-040
Device Catalogue NumberB1080-040
Device Lot Number00521G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/20/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/21/2020
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: 10/22/2020 Patient Sequence Number: 1
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