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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 B2120-060
Device Problems Entrapment of Device (1212); Material Rupture (1546); Material Separation (1562)
Patient Problem Insufficient Information (4580)
Event Date 03/02/2021
Event Type  Injury  
Manufacturer Narrative
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. The additional armada 35 device referenced is filed under a separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a common iliac artery. A 12x40mm armada 35 balloon was advanced to the lesion without resistance. Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially. The device was withdrawn without issue. Then a 12x60mm armada 35 balloon was advanced to the lesion without resistance. Once at the lesion, the balloon was inflated once at 3-4 atmospheres (atm) and ruptured circumferentially. The device was attempted to be removed but met resistance with the anatomy and could not be removed completely. Therefore surgical intervention was performed to successfully remove the device. A non-abbott balloon was used to successfully complete the procedure. There was a clinically significant delay reported. 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 Key11578883
MDR Text Key242662423
Report Number2024168-2021-02451
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSZ
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 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2120-060
Device Catalogue NumberB2120-060
Device Lot Number00515G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/15/2020
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: 03/27/2021 Patient Sequence Number: 1
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