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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 B2120-040
Device Problems Entrapment of Device (1212); Off-Label Use (1494); Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/04/2021
Event Type  Injury  
Manufacturer Narrative
(b)(4). The product was not returned to abbott vascular for analysis. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot or relabeled lot that would have contributed to this event. Based on the review of similar incidents there is no indication of a lot specific product quality issue. In this case, the device was prepped prior to use and inflated two previous times without any leaks/ruptures noted, which would suggest that the device was not damaged prior to use. It should be noted that the instructions for use (ifu) for the , pta, armada 35 / armada 35 ll, global, ce, costa rica instructions for use, states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. This device is also indicated for stent post-dilatation in the peripheral vasculature. Additionally, section iv, warnings/precautions) states: inflation in excess of the rated burst pressure (rbp) may cause the balloon to rupture. Use of a pressure monitoring device is recommended. In this case the reported ifu violations of used in the wrong anatomy and inflation of the balloon above rbp does not appear to have caused or contributed to the reported difficulties as the balloon was inflated two previous times without any issues noted. The investigation determined the reported balloon rupture appears to be related to operational circumstances of the procedure. In this case, it is likely that the balloon became compromised against the anatomy and/or other devices used resulting in the reported balloon rupture. Due to the balloon rupture, the balloon was unable to properly refold and causing resistance during traction or the balloon to get stuck. Further manipulation against resistance ultimately resulted in the reported shaft separation. Additionally, the treatment appears to be related to the operational context of the procedure as the device was removed accessing the opposite vein with a snare kit. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a pulmonary vein. A 12x40mm armada 35 balloon was advanced to the lesion without issue. The balloon was inflated 3 times to 14 atmospheres for 10 seconds, there was no difficulty maintaining pressure, however the balloon ruptured on the 3rd inflation. When simply withdrawing the device from the anatomy, resistance was met with the guide wire and the shaft of the armada broke and did not come out completely. The device was removed accessing the opposite vein with a snare kit. There were no adverse patient sequela 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 Key11893964
MDR Text Key253122697
Report Number2024168-2021-04451
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
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
Report Date 05/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2120-040
Device Catalogue NumberB2120-040
Device Lot Number90910G1
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2019
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: 05/27/2021 Patient Sequence Number: 1
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