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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 14 PTA CATHETER; PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number A2030-120
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/09/2021
Event Type  malfunction  
Manufacturer Narrative
The device is expected to be returned for investigation.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 moderately calcified, mildly tortuous tibial artery that was 75% stenosed.The 3.0x12mm armada 14 balloon dilatation catheter was advanced over a command es guidewire.During inflation, the balloon did not open to its complete profile and a leak was observed from the hub.The device was replaced with a 3.0x200mm armada 14 balloon to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported inflation issue and leak were confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other complaints reported from this lot.The investigation determined that the reported inflation issue and leak were due to a tear noted to the inner member.Although a cause for the tear could not be determined, there was no leak noted during preparation for use indicating that the damage was not pre-existing.Additionally, based on the evaluation of the returned unit and sem analysis, the inner member damage may be attributed to mechanical damage and may suggest that an object was inserted into the inflation port; however, this could not be confirmed.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Na.
 
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Brand Name
ARMADA 14 PTA CATHETER
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key11592418
MDR Text Key244191102
Report Number2024168-2021-02532
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08717648156106
UDI-Public08717648156106
Combination Product (y/n)N
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 06/25/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date03/31/2024
Device Model NumberA2030-120
Device Catalogue NumberA2030-120
Device Lot Number0102141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/13/2021
Initial Date Manufacturer Received 03/10/2021
Initial Date FDA Received03/30/2021
Supplement Dates Manufacturer Received06/24/2021
Supplement Dates FDA Received06/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
COMMAND ES GUIDEWIRE
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