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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 B1040-060
Device Problems Inflation Problem (1310); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/12/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual and functional inspections were performed on the returned device. The inflation issue and irregular balloon fold was not confirmed. It may be possible that the kinked inner member contributed to the inflation issue while in the anatomy preventing the balloon from inflating; however, this could not be confirmed. 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 of the reported lot revealed no other incidents. The investigation was unable to determine a conclusive cause for the reported difficulties. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
It was reported that the procedure was to treat a lesion in the common iliac artery. A 4. 0x60mm armada 35 balloon catheter was advanced to the lesion. An attempt to inflate the balloon was made; however, the balloon dilated irregularly and the positioning part was not dilated (the dilated part was about 10mm distal to the positioning part). The device was removed and it was confirmed that the balloon was fold at the front end portion against the balloon marker. The procedure was successfully completed without additional treatment. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
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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 Key6549481
MDR Text Key74656038
Report Number2024168-2017-03980
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/05/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2017
Device Catalogue NumberB1040-060
Device Lot Number40521G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/28/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/14/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2014
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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