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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 Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2017
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. (b)(4). The customer reported the device was discarded. 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 lesion located in the totally occluded right superficial femoral artery. During preparation of the first armada 18 balloon catheter, a leak was observed at the connection between the rotating hemostatic valve and the balloon. The device was not used on the patient. The second armada 18 balloon was observed to have the same issue. The decision was made to use the balloon catheter and it was used successfully; however, re-wrap of the balloon was not optimal due to the leak. No adverse patient effects or clinically significant delay in the procedure were reported. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis; however, abbott vascular (av) performed an investigation for the reported leak. A review of the complaint handling database found one similar incident from this lot. Av 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 Key6539239
MDR Text Key74410137
Report Number2024168-2017-03832
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 05/10/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/02/2017
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? No
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? Device Not Returned to Manufacturer
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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