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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 1013469-120
Device Problems Deflation Problem; Difficult to Insert; Difficult to Remove
Event Date 11/13/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. The customer reported the device was discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

 
Event Description

It was reported that after inflation of the armada 18 percutaneous transluminal angioplasty (pta) catheter once to 8 atmospheres, the balloon experienced resistance and could not be pulled back into the sheath because it was not fully deflated. Negative pressure was held for 10 seconds. It was able to be removed without issue; however it was unable to be re-inserted back into the sheath. Another balloon was used to complete the procedure. There were no adverse patient effects and there was no clinically significant delay in 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 Key9417748
Report Number2024168-2019-14173
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/15/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/05/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1013469-120
Device LOT Number9013041
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/02/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured01/30/2019
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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