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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 1013470-150
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/25/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for analysis. Abbott vascular (av) reviewed the lot history record and there were no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Av conducted root cause analysis and determined the issue may be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Av will continue to trend the performance of these devices. The other armada 18 referenced is being filed under a separate medwatch mfr number.
 
Event Description
It was reported that the procedure was to treat a lesion in the intra-popliteal artery. A 6x150mm armada 18 balloon catheter failed to inflate and a leak at the hub was noted. A new 6x150mm armada 18 balloon catheter again failed to inflate and a leak at the hub was noted. The procedure was successfully completed with an armada 14 balloon catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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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 Key7242122
MDR Text Key99100347
Report Number2024168-2018-00821
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648208447
UDI-Public08717648208447
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
Report Date 02/05/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1013470-150
Device Lot Number7021041
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 Received01/25/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2017
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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