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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 1014254-120
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/12/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a mildly tortuous and mildly calcified de novo mid superficial femoral artery that was 80% stenosed. A 3. 0 x 120 mm armada 18 balloon catheter was advanced to the lesion and inflated when it was noted that the balloon markers were not in the correct location. Another device 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.

 
Manufacturer Narrative

(b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported misplaced markers was not confirmed. 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 incidents. The investigation was unable to determine a conclusive cause for the reported difficulty. 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.

 
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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 Key6620297
MDR Text Key76964939
Report Number2024168-2017-04863
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeBE
PMA/PMN NumberK151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 07/13/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received06/07/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/29/2020
Device Catalogue Number1014254-120
Device LOT Number6090741
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer06/19/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/12/2017
Was Device Evaluated By Manufacturer? Yes
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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