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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2025-080
Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310); Occlusion Within Device (1423)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/11/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion located in the mid posterior tibial artery that was moderately calcified. A guide wire crossed the occluded segment and during aspiration, the armada 14 2. 5 x 80 mm percutaneous transluminal angioplasty catheter balloon was leaking as part of the initial purge of air from the balloon using syringe of contrast. The balloon only partially inflated. When the device was withdrawn, there was blood in the balloon. A new unspecified balloon was used to complete the procedure. There was no reported adverse patient effect. There was no reported clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: a visual and functional inspection was performed on the returned device. The reported inflation issue and leak were confirmed due to a balloon rupture. 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. Based on the information provided, the reported difficulties appear to be due to operational circumstances of the procedure. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameARMADA 14 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7574782
MDR Text Key110361729
Report Number2024168-2018-04203
Device Sequence Number1
Product Code LIT
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,foreig
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/13/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2019
Device Catalogue NumberA2025-080
Device Lot Number6051841
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer06/05/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No

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