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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 Detachment Of Device Component (1104); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/03/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Evaluation summary: visual inspection was performed on the returned device. The reported balloon rupture and separation were 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. The investigation determined that the reported difficulties were due to case circumstances. 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 clot in the right femoral / right common iliac vein. Catheter assisted thrombolysis (ekos) was used. Post ekos, an armada 35 10 mm / 40 mm balloon was advanced from femoral to iliac vein. The armada was inflated twice and ruptured at 12 atmospheres near the previously implanted stents in the iliac vein. Angiography showed the distal end of the balloon was knotted and stuck on the guide wire and half the balloon was in the guiding catheter. The knotted portion of the balloon that was stuck on the guide wire was eventually safely removed when the sheath was upsized to a 14 french. Nothing was ever free-floating. The device was prepped according to the ifu. There was no resistance noted during advancement in the anatomy. 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 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 Key7223353
MDR Text Key98774936
Report Number2024168-2018-00638
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 01/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberB1100-040
Device Lot Number70522G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/16/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/03/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
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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