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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 B1080-080
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 08/24/2020
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the basilic vein. An 8x80mm armada 35 balloon catheter was inflated two times; however, the balloon ruptured circumstantially during the second inflation at 14 atmospheres. During removal of the balloon catheter resistance with the introducer sheath was felt and the distal portion of the ruptured balloon separated. The procedure was successfully completed by deploying an 8x60mm absolute pro stent to embed the separated balloon piece against the vessel wall. There was no clinically significant delay in the procedure. 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 Key10516411
MDR Text Key206492843
Report Number2024168-2020-07562
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-080
Device Catalogue NumberB1080-080
Device Lot Number91102G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/02/2019
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: 09/10/2020 Patient Sequence Number: 1
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