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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 B2140-040
Device Problems Break; Off-Label Use; Improper or Incorrect Procedure or Method
Event Date 10/04/2019
Event Type  Malfunction  
Manufacturer Narrative

Exemption number e2019001. The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. (b)(4).

 
Event Description

It was reported that the procedure was to treat the aorta that did not have any tortuosity or calcification. A 14 x 40 mm armada 35 balloon catheter was used and did not meet any resistance during advancement. It was inflated once to nominal pressure without issues. The balloon may have been deflated for less than 5 seconds and was fully deflated without issues. After it was deflated and removed from the anatomy, the balloon was noted to have "peeled off" (lifted off) the catheter; however, the balloon was still attached to the device. It was confirmed under fluoroscopy that no foreign material was left in the anatomy. Additionally, the device did not meet any resistance during removal. There were no adverse patient effects 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 Key9257435
Report Number2024168-2019-13049
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/30/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/30/2019
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberB2140-040
Device LOT Number90819G1
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/22/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/19/2019
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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