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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 B1120-080
Device Problems Off-Label Use; Difficult to Remove ; Material Rupture; Material Separation; Improper or Incorrect Procedure or Method
Event Date 07/15/2019
Event Type  Malfunction  
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 will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na.

 
Event Description

It was reported that the procedure was performed to treat an 80% stenosed lesion in the left subclavian vein. A 7fr sheath was advanced and a 12 x 80 mm armada 35 balloon catheter was advanced without resistance; however, the balloon ruptured during the first inflation at 9 atmospheres. An attempt to remove the balloon catheter was made, but the balloon would not go back through the sheath due to the balloon material bunching up at the tip of the sheath and became stuck. An attempt to forcibly remove the balloon catheter was made, but the balloon catheter separated into two pieces. The balloon catheter was removed, but the distal tip of the balloon material remained lodged in the tip of the sheath. A buddy wire was passed through the site to retain wire access as a new perma-catheter was inserted. The old wire, sheath, and balloon remnants were removed as a single unit. A non-abbott balloon catheter was used to successfully complete the procedure. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.

 
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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 Key8895591
Report Number2024168-2019-10873
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/09/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received08/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB1120-080
Device LOT Number90220G1
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 Received08/17/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/20/2019
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: 08/14/2019 Patient Sequence Number: 1
Treatment
INTRODUCER SHEATH: 7FR ANSEL SHEATH
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