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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 B2080-040
Device Problems Entrapment of Device (1212); Difficult to Remove (1528); Material Rupture (1546); Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/16/2022
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a heavily calcified, mildly tortuous, de novo lesion in the right common femoral artery. After an unspecified stent was implanted in the right common femoral artery, post-dilatation was being performed with an 8x40mm armada 35 balloon dilatation catheter (bdc), when the balloon ruptured due to the heavy calcification at the lesion. The bdc was then being removed from the anatomy when it became stuck with the tip of the sheath. It was decided that the bdc and sheath would be removed from the lesion as a single unit, however the balloon became stuck in calcium, while the sheath was removed intact. The bdc became separated, and the tip of the device was left inside the vessel. The patient was put under general anesthesia (ga), and a cut down procedure was performed to successfully remove the ruptured balloon from the anatomy. There was no adverse patient sequela, however there was a reported clinically significant delay due to the cut down procedure. No additional information was provided.
 
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.
 
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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 Key14017391
MDR Text Key288786218
Report Number2024168-2022-03579
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 04/05/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2080-040
Device Catalogue NumberB2080-040
Device Lot Number10819G1
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/19/2021
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: 04/05/2022 Patient Sequence Number: 1
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