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U.S. Department of Health and Human Services

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

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AV-TEMECULA-CT ARMADA 14 XT PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number F2020-020
Device Problems Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Use after expiration. Indication for use. 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 a 2. 0x20mm armada 14 otw balloon catheter was used after expiration. The date of expiration is (b)(6) 2015; however, the balloon catheter was used on (b)(6) 2018. It was further reported that this device had been sent as a demo device. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents from this lot. It should be noted that he armada 14xt instructions for use states: note the use by date specified on the package. The investigation determined the reported complaint was due to user error. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the previously filed report, additional information was received: the expired 2. 0x20mm armada 14 otw balloon dilatation catheter (bdc) was being used to treat a stenosis in the infrapopliteal (below the knee). The bdc was used without issue to successfully complete the procedure. No additional information was provided.
 
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Brand NameARMADA 14 XT PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7789880
MDR Text Key117432980
Report Number2024168-2018-06301
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 09/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2015
Device Catalogue NumberF2020-020
Device Lot Number21219G1
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/07/2018
Is This a Reprocessed and Reused Single-Use Device? No

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