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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 B1050-060
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Physical Property Issue (3008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was not returned for evaluation. 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 was unable to determine a conclusive cause for the reported difficulties. 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 after unpackaging and prepping a 5. 0mm x 60mm x 80cm armada 35 balloon dilatation catheter (bdc) without issue, the bdc was advanced via right brachial access to a non-calcified, non-tortuous arterio-venous (av) fistula without resistance. The armada 35 was inflated without difficulty, but inflation reportedly felt unusual. Dilatation was completed without difficulty, however, the balloon was unable to be deflated at all and was consequently difficult to remove from the av fistula. Force was applied to retract and wedge the inflated balloon into the guiding catheter then all devices were withdrawn from the anatomy as a single unit. There were no adverse patient effects and no occurrence of a clinically significant delay. 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 Key6294284
MDR Text Key66563885
Report Number2024168-2017-00853
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 02/01/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/01/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/29/2020
Device Catalogue NumberB1050-060
Device Lot Number60922G1
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 Received01/12/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/01/2016
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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