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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER
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AV-TEMECULA-CT ARMADA 18 PTA CATHETER; PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013466-100
Medical Device Problem Code Difficult to Remove (1528)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 08/29/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional analysis was performed on the returned devices.The reported difficulty removing from the guide wire 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 other incidents.The investigation determined the difficulties were likely due to case circumstances.It is likely that the clearance between the guide wire lumen of the armada 18 otw and the guide wire became reduced causing resistance.Further attempts to move the bdc from the guide wire likely caused the devices to become frozen together resulting in difficulty removing.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the popliteal artery that was heavily calcified.The armada 18 4 x 100 mm percutaneous transluminal angioplasty balloon was inflated twice for treatment.During removal, there was resistance with the non-abbott guide wire and both devices were removed as a single unit.There was no reported adverse patient effect.There was no reported clinically significant delay in the procedure.No additional information was provided.
 
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Brand Name
ARMADA 18 PTA CATHETER
Common Device Name
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7857825
Report Number2024168-2018-06984
Device Sequence Number13735588
Product Code LIT
UDI-Device Identifier08717648207983
UDI-Public08717648207983
Combination Product (Y/N)N
Initial Reporter StateOH
Initial Reporter CountryUS
PMA/510(K) Number
K151317
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Remedial Action Other
Type of Report Initial
Report Date (Section B) 09/07/2018
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
Operator of Device Health Professional
Device Expiration Date03/31/2021
Device Catalogue Number1013466-100
Device Lot Number7102441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2018
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 08/29/2018
Initial Report FDA Received Date09/07/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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