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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 A1030-120
Device Problems Device Expiration Issue (1216); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was not returned for analysis. The reported information of using the product after the expiration date appears to be user related. 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 the armada 14 instruction for use states: use prior to the use by date. The investigation determined the reported issue was due to user error. Based on the information reviewed, 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 an unspecified peripheral artery. A 3. 0 x 120 mm armada 14 balloon dilatation catheter was used (bdc); however, the device was used past its expiration date because it was used on (b)(6) 2018 and the use by date was on 12/31/2017. 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 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 Key7290482
MDR Text Key100911247
Report Number2024168-2018-01322
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 02/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/31/2017
Device Catalogue NumberA1030-120
Device Lot Number4070141
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 Received02/12/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2014
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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