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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 B1080-040
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/09/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).Internal file number - (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 relevant information.
 
Event Description
It was reported the procedure was performed to treat a lesion with heavy calcification in the iliac artery.An 8 x 40 mm armada 35 balloon was inflated and deflated without any issue.However, during removal of the device, resistance was felt with the anatomy and the balloon separated.The separated portion of the balloon remained in the common femoral artery.It was confirmed there was no force applied during withdrawal of the device.Surgery was performed later that day to extract the separated portion of the balloon which was in arterial wall at the puncture site level.The patient condition is good.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Visual analysis was performed on the returned device.The reported balloon separation was confirmed.The difficulty removing was not tested due to the condition of the device.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.The investigation determined that the reported difficulties and subsequent treatment was due to case circumstances.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 Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL 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 Key7310655
MDR Text Key101415225
Report Number2024168-2018-01524
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/06/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2021
Device Catalogue NumberB1080-040
Device Lot Number71114G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/09/2018
Initial Date FDA Received03/02/2018
Supplement Dates Manufacturer Received04/03/2018
Supplement Dates FDA Received04/06/2018
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
Patient Sequence Number1
Treatment
SHEATH: 7FR
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age50 YR
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