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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 1014255-100
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/12/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. (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 70% stenosed and moderately calcified lesion in popliteal artery. A 4. 0x100mm armada 18 balloon catheter was not prepped outside the anatomy prior to use. The balloon ruptured at 10 atmospheres during the first inflation. The procedure was successfully completed with a new unspecified armada 18 balloon catheter. There were no adverse patient effects and 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 Key9411194
MDR Text Key177765258
Report Number2024168-2019-14113
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeSN
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 12/26/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/04/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date10/31/2020
Device Catalogue Number1014255-100
Device LOT Number7053041
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 Received12/07/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/30/2017
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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