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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013470-200
Device Problems Break (1069); Leak/Splash (1354); Loose or Intermittent Connection (1371); Physical Property Issue (3008)
Patient Problem No Patient Involvement (2645)
Event Date 03/16/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
Reportedly, while attempting to prepare a 6x200mm armada 18 percutaneous transluminal angioplasty (pta) catheter a negative was pulled; however, it was noticed that the hub was leaking (bubbles were noticed). The indeflator was disconnected from the device and the device was inspected. It was noticed that the hub was not formed correctly/broken; which didn't allow the devices to connect properly. The device was not used and the procedure was successfully completed with a new 6x200mm armada 18 pta. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided. Although, initial testing of the returned device indicated that the balloon fully inflated to nominal pressure of 8 atmospheres without any leaks observed, additional testing was done and a leak was noted coming from the distal end of the hub at 6 atmospheres.
 
Manufacturer Narrative
(b)(4). Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak in the distal end of the hub. A review of the complaint handling database found one similar incident from this lot. Av reviewed the lot history record and there were no manufacturing nonconformities that would have contributed to this complaint. Av conducted root cause determined the most probable root cause is variability in the gluing process during manufacturing. The issue will be addressed per internal operating procedures. Av will continue to trend the performance of these devices.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key6488960
MDR Text Key72936576
Report Number2024168-2017-03115
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue Number1013470-200
Device Lot Number6091541
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/22/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/03/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2016
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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