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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number A2030-060
Device Problems Inflation Problem (1310); Material Rupture (1546)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/19/2021
Event Type  malfunction  
Manufacturer Narrative
A visual and functional inspection was performed on the returned balloon catheter and the reported inflation issue was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot. The device was prepped prior to use without any leak or ruptures noted, which would suggest that the device was not damaged prior to use. The investigation determined the reported inflation issue, noted balloon rupture and balloon scratch appear to be related to operational circumstances of the procedure. Based on the reported information and returned analysis, it is likely that during advancement through the severe calcified and mild tortuosity anatomy the balloon outer surface became damaged resulting in the noted balloon rupture/leak during inflation. The noted scratch at the rupture site also suggests interaction causing damage to the outer surface of the balloon material. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a lesion with severe calcification and mild tortuosity in the left anterior tibial artery. The 3. 0 x 60 mm armada 14 balloon catheter crossed the lesion; however, during an attempt to inflate the balloon to nominal pressure, the pressure did not increase. Therefore, the balloon catheter was removed without issue. A new armada 14 balloon was used successfully. There were no adverse patient effects and no clinically significant delay in the procedure. The returned device analysis identified a pinhole in the balloon material 2. 7cm distal to the proximal marker. No additional information was provided.
 
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Brand NameARMADA 14 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 Key11986313
MDR Text Key255951864
Report Number2024168-2021-04933
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 06/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberA2030-060
Device Catalogue NumberA2030-060
Device Lot Number9071641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/29/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/16/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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