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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 1014258-150
Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/04/2019
Event Type  Injury  
Manufacturer Narrative

(b)(4). 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 the procedure was performed to treat a heavily calcified lesion in the superficial femoral artery. Resistance with the calcified anatomy was felt during advancing and removal of a 6. 0x150mm armada 18 balloon catheter and the distal shaft with the balloon separated inside the patient anatomy. The separated portion was not able to be snared out. The patient was given a general anesthetic and a femoral cutdown was performed to retrieve the separated segment. A delay in procedure due to the cutdown was reported. 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 Key9512234
MDR Text Key175894253
Report Number2024168-2019-14941
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeAS
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 02/06/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number1014258-150
Device LOT Number8030741
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 Received01/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/07/2018
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: 12/23/2019 Patient Sequence Number: 1
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