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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
Catalog Number B1080-060
Device Problems Material Rupture (1546); Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2023
Event Type  Injury  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.H6: device code 2017 clarifier - above rated burst pressurena.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the hepatic trunk artery.The 8x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter met resistance during advancement due to the lesion; however, was inflated twice up to 12 atmospheres and a rupture occurred.During removal the device separated into two pieces and a fragment became stuck on the wire; therefore, a loop snared was used to retrieve the separated balloon fragment.There were no reported adverse patient sequela and no clinically significant delay.No additional information was provided.
 
Manufacturer Narrative
Visual inspection was performed on the returned device.The reported balloon rupture and separation were confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was based on operational circumstances.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history identified no other similar incidents and/or complaints from this lot.The investigation determined the reported difficulty advancing the device, separation and unexpected medical intervention appear to be related to operational context; however, a conclusive cause for the reported balloon rupture could not be determined.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.H6- device code 2017 was removed.
 
Event Description
It was reported that the procedure was performed to treat a lesion in the hepatic trunk artery.The 8x60mm armada 35 percutaneous transluminal angioplasty (pta) catheter met resistance during advancement due to the lesion; however, was inflated twice up to 12 atmospheres and a rupture occurred.During removal the device separated into two pieces and a fragment became stuck on the wire; therefore, a loop snared was used to retrieve the separated balloon fragment.There were no reported adverse patient sequela and no clinically significant delay.No additional information was provided.
 
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Brand Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL 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 Key18030707
MDR Text Key326863627
Report Number2024168-2023-11959
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648154874
UDI-Public08717648154874
Combination Product (y/n)N
Reporter Country CodeNZ
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 Physician
Type of Report Initial,Followup
Report Date 01/08/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/30/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberB1080-060
Device Lot Number30222G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/19/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/22/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Weight130 KG
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