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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 1014258-040
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. The device was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat a mildly calcified lesion in the mildly tortuous popliteal artery with 30% stenosis. The 6. 0x40 mm armada 18 percutaneous transluminal angioplasty (pta) catheter was used for post-dilatation and no resistance was noted during advancement. The pta catheter was inflated once to 8 atmospheres (atm) and negative pressure was held for 20 seconds to fully deflate the balloon. During removal, resistance was noted and it was seen that the balloon was stuck in the sheath. The sheath and the armada 18 were removed as a single unit. There were no adverse patient effects and there was no clinically significant delay in the procedure. A new sheath and a new armada 18 were used to complete 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 Key9477837
MDR Text Key178114367
Report Number2024168-2019-14612
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeAU
PMA/PMN NumberK151317
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 02/03/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/17/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1014258-040
Device LOT Number9081441
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/12/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/13/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/14/2019
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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