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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B1140-040
Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528)
Patient Problem Foreign Body In Patient (2687)
Event Date 04/14/2017
Event Type  Injury  
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. Evaluation summary: visual, dimensional and functional inspection was performed on the returned device. The reported resistance and separation was confirmed. It is likely that during use, the clearance between the guide wire and guide wire lumen of the armada 35 became reduced causing the reported resistance. Additional movement of the catheter against resistance likely resulted in the device become frozen together and during the attempt to remove the armada 35, the separation occurred. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, there is no indication of a lot specific product issue. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a highly stenosed lesion in the vena cava artery. A 14 x 40 mm armada 35 balloon separated while inside the patient. The separated portion was not recovered. Additionally, resistance with an unknown guide wire was felt when advancing and withdrawing the device. It is unknown as to how many atmospheres the balloon was inflated because it was inflated with hand injections. 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 35 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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key6560307
MDR Text Key74936177
Report Number2024168-2017-04064
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
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 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2020
Device Catalogue NumberB1140-040
Device Lot Number61102G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/20/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
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: 05/11/2017 Patient Sequence Number: 1
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