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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B1050-060
Device Problems Difficult to Remove (1528); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/20/2018
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 de novo lesion located in the mid femoral vein that was mildly tortuous, mildly calcified and 80% stenosed. A femoral dilatation was performed with the armada 35 5 x 60 mm percutaneous transluminal angioplasty catheter. After the balloon was fully deflated, it was difficult to move the delivery system over the non-abbott 0. 035 guide wire to remove it from the patient anatomy. There was a lot of resistance but the device was finally removed successfully as a single unit. The proximal part of the balloon was reported to be very narrow and very difficult to slide over the wire. 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). The device was returned for analysis. Visual and functional inspections were performed. The reported difficulties were confirmed. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. 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 incidents from this lot. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameARMADA 35 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
EL COYOL, COSTA RICA REG# 3009031392
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7425783
MDR Text Key105419072
Report Number2024168-2018-02720
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeBE
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2021
Device Catalogue NumberB1050-060
Device Lot Number71127G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/10/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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