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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 B1120-040
Device Problems Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 06/05/2020
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 the procedure was performed to treat a lesion in a previously created right radiocephalic arteriovenous (av) fistula. The patient has a history of stenosis of the subclavian/innominate vein, causing arm swelling, with implantation of an unspecified stent to treat the stenosis. The patient presented with swelling in her right arm and the procedure was performed to treat stenosis of the av fistula. The 12. 0 x 40 mm armada 35 dilatation catheter was advanced to the target site. The balloon was inflated to 5 atmospheres (atm) and the balloon ruptured. An attempt was made to remove the dilatation catheter; however, resistance was noted and it was obvious that something was preventing the removal of the device. The dilatation catheter was able to come out of the sheath, but it could not be removed from the guide wire. It appeared that the tip of the catheter and balloon may have separated and remained in the anatomy. Angiography noted that the balloon marker was caught on the previously implanted stent. The dilatation catheter was cut and removed from the guide wire. A 6 french non-abbott sheath was then advanced over the guide wire and the guide wire was removed. It appeared that the ruptured balloon had wrapped around the guide wire, causing the difficult removal. Angiography noted the distal radiopaque balloon marker in the subclavian vein. The decision was made to implant a covered stent to cover the entire area. Additional post dilatation was performed and final angiography noted that the stent was widely patent. 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 Key10172131
MDR Text Key195705918
Report Number2024168-2020-05168
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1120-040
Device Catalogue NumberB1120-040
Device Lot Number00203G2
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/15/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2020
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: 06/18/2020 Patient Sequence Number: 1
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