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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1014262-040
Device Problem Leak/Splash (1354)
Patient Problem Air Embolism (1697)
Event Date 06/14/2018
Event Type  Malfunction  
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 is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information. The absolute pro ll device referenced is being filed under a separate medwatch manufacturer report reference number.

 
Event Description

It was reported that the procedure was to treat a moderately tortuous, heavily calcified de novo lesion in the mid femoral artery. A 4. 0 x 40mm armada balloon dilatation catheter was advanced to the lesion, but air was noted as leaking from the catheter. Then a 7. 0 x 120mm absolute pro stent-delivery system crossed the lesion without issue. During deployment, about 1/3 of the stent was partially deployed. The release mechanism got hard, resistance was felt until a break occurred, which consequently broke the stent in pieces. The stent was removed, but some pieces remained in the artery. Then three omnilink elite (ole) stents were used to treat the lesion. The physician had one of the ole stents deploy over the portion of the absolute pro stent that remained in the artery. No additional information was provided.

 
Search Alerts/Recalls

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Brand NameARMADA 18 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)
CLONMEL, IRELAND REG# 9616693
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 Key7632740
MDR Text Key112141776
Report Number2024168-2018-04903
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeBR
PMA/PMN NumberK151317
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 10/01/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received06/24/2018
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date06/30/2020
Device Catalogue Number1014262-040
Device LOT Number7013041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer09/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/18/2018
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

Patient TREATMENT DATA
Date Received: 06/24/2018 Patient Sequence Number: 1
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