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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 A2040-080
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/14/2016
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 was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was to treat a lesion located in the left superficial femoral artery that was non tortuous, mildly calcified and 90% stenosed. The armada 14 pta catheter was being used for pre-dilatation, and during angiography, it was observed that the proximal edge of the proximal marker was located 5-8mm distal to the proximal shoulder into the balloon working length. Despite this being observed, the armada 14 balloon catheter was continuously used and inflated in the lesion at 10 atmospheres. There was no resistance during advancement to the lesion. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.

 
Manufacturer Narrative

Internal file number - (b)(4). Evaluation summary: visual and dimensional inspections were performed on the returned device. The reported mislocated balloon markers were not confirmed. The investigation was unable to determine a conclusive cause for the reported difficulty. 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 identified no other incidents from this lot. 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 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 Key6011625
MDR Text Key57270621
Report Number2024168-2016-06757
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK102705
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 11/02/2016
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/07/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date02/28/2019
Device Catalogue NumberA2040-080
Device LOT Number5090941
Was Device Available For Evaluation? Yes
Date Returned to Manufacturer10/05/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/01/2015
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: 10/07/2016 Patient Sequence Number: 1
Treatment
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