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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
Catalog Number A2020-200
Device Problems Inflation Problem (1310); Leak/Splash (1354); Loose or Intermittent Connection (1371)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/27/2019
Event Type  malfunction  
Manufacturer Narrative
Exemption number (b)(4) permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.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 the subclavian artery.The 2.0 x 200 mm armada 14 balloon dilatation catheter leaked air and contrast from the connection point with a non-abbott inflation device when pressurized to 6 atmospheres.The balloon only partially inflated.Per the physician, there was a connection issue with the inflation device.A new unspecified balloon catheter was used to successfully complete the procedure using the same non-abbott inflation device.There were no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
Visual and dimensional inspection was performed.The reported leak was confirmed.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 of the reported lot revealed no incidents.The investigation determined that the reported leak appears to be related to a product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.
 
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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 Key9076065
MDR Text Key158997291
Report Number2024168-2019-11825
Device Sequence Number1
Product Code DQY
UDI-Device Identifier08717648155994
UDI-Public08717648155994
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 12/20/2019
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 Date07/31/2022
Device Catalogue NumberA2020-200
Device Lot Number9022541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2019
Initial Date Manufacturer Received 08/27/2019
Initial Date FDA Received09/17/2019
Supplement Dates Manufacturer Received12/02/2019
Supplement Dates FDA Received12/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
MERITON INFLATION DEVICE; MERITON INFLATION DEVICE
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