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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2040-120
Device Problems Detachment Of Device Component (1104); Deflation Problem (1149); Difficult to Remove (1528); Stretched (1601)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/16/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Estimated weight. The removed portion of the device remains with the hospital risk management and the separated portion remains in the patient's anatomy. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that this was a percutaneous interventional procedure treating a popliteal deep vein thrombosis. An armada dilatation catheter was advanced to the popliteal lesion and multiple balloon inflations were performed without issues. Following the last inflation, the balloon was unable to deflate. The indeflator was removed from the device and a syringe was attached to manually deflate the balloon. The balloon would still not deflate. A buddy wire advanced to puncture the balloon; however, this was also unsuccessful. The armada catheter was twisted and torqued, to try to remove. The unspecified wire and the distal end of the armada catheter, with the still inflated balloon, had stretched and then separated. An access needle was advanced and punctured the inflated balloon. The separated distal end of the armada, containing the balloon, and the separated wire remain in the patient's anatomy. There were no clinical symptoms. No additional information was provided regarding this issue.
 
Manufacturer Narrative
(b)(4). The device was not returned for analysis. 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 reported from this lot. The investigation determined the reported difficulties of deflation issue, difficulty to remove, shaft separation, stretched shaft patient effect and additional treatment appear to be related to circumstances of the procedure as an access needle was advanced and punctured the inflated balloon and the separated section of the device remains in the patient. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameARMADA 14 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 Key7573655
MDR Text Key110227270
Report Number2024168-2018-04188
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K102705
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,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/06/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/31/2021
Device Catalogue NumberA2040-120
Device Lot Number7121241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/01/2017
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: 06/06/2018 Patient Sequence Number: 1
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