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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2050-120
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/14/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device was reported to be discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.

 
Event Description

It was reported that the procedure was to treat a lesion in a superficial femoral artery. Angioplasty was performed with an armada 35 percutaneous transluminal angioplasty (pta) catheter. During the procedure, it was noted the proximal balloon marker was about 10-20mm proximal to the balloon. The procedure was successfully completed with the armada 35. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

 
Manufacturer Narrative

(b)(4). The device was not returned for analysis. The investigation was unable to determine a conclusive cause for the reported difficulty. A review of the lot history record revealed no manufacturing nonconformities for the reported lot. Additionally, a review of the complaint history of the reported lot revealed no other incidents. 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 35 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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key5574449
MDR Text Key42797151
Report Number2024168-2016-02380
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/22/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/13/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2016
Device Catalogue NumberB2050-120
Device LOT Number30214G1
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 Received04/14/2016
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2013
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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