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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 B1080-080
Device Problems Off-Label Use; Difficult to Remove ; Material Rupture; Material Separation; Difficult to Advance; Material Twisted / Bent
Event Date 10/23/2018
Event Type  Injury  
Manufacturer Narrative

(b)(4). The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all relevant information.

 
Event Description

It was reported that the procedure was performed to treat a totally occluded, mildly tortuous, non-calcified lesion in the axillary artery. An 8x80mm x 80cm armada 35 percutaneous transluminal angioplasty (pta) catheter was advanced to the lesion with expected resistance due to the occlusion. During the first inflation at an unknown pressure the balloon ruptured circumferentially and separated into three pieces. Resistance was noted with the anatomy and guide wire during removal of the pta catheter; force was used during device removal, and the distal catheter buckled. The proximal portion of the pta catheter was ultimately pulled out on the guide wire, and another unspecified device was used to push the separated distal shaft and balloon out of the exit site. It was confirmed that no part of the device remained in the patient anatomy. Another unspecified balloon device was used to complete the procedure. No additional information was provided.

 
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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 Key8061290
Report Number2024168-2018-08704
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 03/11/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received11/12/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1080-080
Device LOT Number80220G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/15/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/01/2018
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: 11/12/2018 Patient Sequence Number: 1
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