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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 1014263-080
Device Problem Torn Material
Event Date 01/06/2016
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 is expected to be returned for investigation. 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 disease in the femoral artery. The armada 18 percutaneous transluminal angioplasty (pta) catheter was advanced and used for dilatation. No deflation issue was noted, however, when the armada 18 pta catheter was retracted into the sheath, the balloon tore. The armada 18 pta catheter and all other devices were removed as a single unit without issue. The procedure was successfully completed with another unspecified device. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

 
Manufacturer Narrative

(b)(4). Evaluation summary: the device was returned for evaluation and the reported tear/separation was confirmed. Based on visual analysis of the returned device, there is no indication of a product quality issue with respect to manufacture, design, or labeling. A conclusive cause for the difficulty could not be determined. A review of the lot history record revealed no non-conformances. A query of the electronic complaint handling database revealed no other incidents reported from this lot. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.

 
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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 Key5439565
Report Number2024168-2016-00887
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/02/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/16/2016
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 Number1014263-080
Device LOT Number5093041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2016
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/29/2016
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

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