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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B1080-080
Device Problems Off-Label Use; Material Rupture; Material Separation
Event Date 07/10/2019
Event Type  Injury  
Manufacturer Narrative

Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition. There may be gaps in numbering for reports submitted during the transition period. 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. Na. [mw5088250].

 
Event Description

It was reported that an 8x80mm armada 35 percutaneous transluminal angioplasty (pta) balloon ruptured. During withdrawal, the marker separated from the catheter in the subclavian artery. The marker then migrated to the pulmonary artery. A snare was attempted several times to retrieve the marker but was unsuccessful. The procedure was then complete and computed tomographic (ct) angiography was performed to evaluate the patient, which did not identify any pulmonary embolism. The patient was expected on (b)(6) 2019 for a follow up evaluation. There was no reported clinically significant delay in the procedure. No additional information was provided. User facility medwatch report received that states: "during an interventional radiology procedure, right arm fistulogram, the balloon catheter ruptured and while attempting to withdraw the catheter from the body, the market tip separated from the catheter in the subclavian artery. The catheter marker tip migrated to pulmonary artery. The dr attempted multiple times to snare the marker tip and was successful. The dr ended the case and send pt to ct for further evaluation. Fda safety report id#(b)(4). ".

 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS 
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula , CA 92591-4628
9519143996
MDR Report Key8860162
Report Number2024168-2019-10571
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/05/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1080-080
Device LOT Number90314G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/08/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured03/14/2019
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: 08/05/2019 Patient Sequence Number: 1
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