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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
Model Number B1070-080
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 06/16/2021
Event Type  Injury  
Manufacturer Narrative
The device is expected to be returned for evaluation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that supera stents were implanted in the right superficial femoral artery without issue. A 7x80mm armada 35 percutaneous transluminal angioplasty (pta) catheter was then advanced with an unspecified 6f sheath to the heavily calcified, mildly tortuous, 95% stenosed, de novo common femoral artery lesion. The balloon ruptured at nominal pressure. The armada pta catheter felt resistance with the sheath during removal, and the balloon separated in the sheath. The sheath, pta catheter, and an unspecified guide wire were removed together. While advancing another unspecified guide wire and sheath, what appeared to be a piece of the balloon was noted to be caught in the supera stent. A non-abbott balloon was inflated and a covered stent were used to embed the separated portion of balloon against the vessel wall. There were no adverse sequelae 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 Key12102059
MDR Text Key259664787
Report Number2024168-2021-05653
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1070-080
Device Catalogue NumberB1070-080
Device Lot Number90622G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2019
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: 07/01/2021 Patient Sequence Number: 1
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