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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 B2050-120
Device Problems Inflation Problem (1310); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a right superior femoral artery (sfa). A 5. 0x120mm armada 35 catheter was attempted to be advanced, but the balloon could not cross the tortuous iliac through left common femoral artery. The physician re-inserted same device through the other access site and was able to access the lesion with the balloon via foot access. Once at the lesion unknown pressure was added once, but the balloon failed to inflate. Another unspecified device was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay. No additional information was provided. *device analysis noted there were multiple tears throughout the entire length of the balloon. *the affiliate confirmed at the end of the procedure there were multiple tears visible throughout the entire length of the balloon. 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 Key10474550
MDR Text Key205187515
Report Number2024168-2020-07249
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 09/28/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2050-120
Device Catalogue NumberB2050-120
Device Lot Number00121G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/21/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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