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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014253-060
Device Problems Inflation Problem (1310); Stretched (1601)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/11/2023
Event Type  malfunction  
Manufacturer Narrative
Visual and functional inspections were performed on the returned device.The reported inflation issue was not confirmed.After leaving the pressurized balloon catheter soaking in warm water bath overnight, the balloon inflated and maintained pressure of 14atm.There was no leak noted.Additionally, it was noted that the shaft was stretched proximal to the proximal seal.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 similar incidents and/or complaints from this lot.A cine was received and reviewed by an abbott vascular clinical specialist.The reviewer concluded that there are two images attached to this report, which may show a pre and post image of which looks like the target lesion in the tibial artery.However, the two images are different views/angles of the supposed lesion and does not clearly show the bdc within the lesion, if it is in the vessel at all.Without knowing more details on what equipment/products were used to treat the lesion and without knowing more details on the lesion morphology (calcification, tortuosity, percent stenosis), as well as not knowing if the bdc was prepped per ifu, a conclusion for probable cause of the event cannot be made.The noted stretched shaft was possibly due to manipulation of the device during preparation.The investigation was unable to determine a conclusive cause for the reported inflation issue.There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a lesion in right anterior tibial artery.The 2.50x60mm armada balloon dilatation catheter (bdc) was advanced to the target lesion and attempted to be inflated; however, the balloon failed to inflate.There was no adverse patient effect and no clinically significant delay reported in the procedure.Return device analysis found the shaft of the bdc was stretched.No additional information was provided.
 
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Brand Name
ARMADA 18 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, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI  
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key16480977
MDR Text Key310675056
Report Number2024168-2023-02196
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K151317
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
Report Date 03/03/2023
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 Catalogue Number1014253-060
Device Lot Number2071941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2023
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/24/2023
Initial Date FDA Received03/03/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2022
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 Age38 YR
Patient SexMale
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