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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2030-200
Device Problems Loose or Intermittent Connection (1371); Melted (1385)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/24/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual and functional inspections were performed on the returned device. The leak was confirmed. The investigation was unable to determine a conclusive cause for the leak. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other similar incidents. 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 mildly calcified anterior tibial artery. A 3. 0 x 200 mm armada 14 balloon catheter was advanced to the lesion; however, when attempting to inflate the device there was a leak at the connection to the stopcock and the catheter. There was no loose connection so the stopcock was changed to a new one; however, there was still a leak at the connection. There was no damage noted to the hub of the catheter. The catheter was removed and another 3. 0 x 200 mm armada 14 was successfully used to complete the procedure. There was no clinically significant delay in procedure and no adverse patient effects. No additional information was provided. Returned device analysis revealed there was a leak at the glue port on the side arm of the armada 14 catheter.
 
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Brand NameARMADA 14 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 Key6544501
MDR Text Key74594730
Report Number2024168-2017-03920
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
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 05/04/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/04/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2019
Device Catalogue NumberA2030-200
Device Lot Number6021041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/29/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/10/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/01/2016
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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