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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 B1100-040
Device Problems Crack (1135); Leak/Splash (1354); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation summary: abbott vascular (av) analyzed the returned device and confirmed the reported leak and cracked hub. The reported hole in the lumen 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 identified no other similar incidents from this lot. Av conducted root cause analysis and determined the most probable cause was related to the manufacture of the device. The issue will be addressed per internal operating procedures. Av will continue to trend the performance of these devices.
 
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was received. The 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 in the distal femoral artery. A leak was noticed on a 10x40mm armada 35 balloon catheter. It was then noticed that the hub had a crack and there was a hole in the lumen. 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 Key6728500
MDR Text Key118455430
Report Number2024168-2017-06050
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNL
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,Followup
Report Date 09/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/20/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2020
Device Catalogue NumberB1100-040
Device Lot Number70117G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/22/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2017
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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