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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 B1090-060
Device Problems Detachment Of Device Component (1104); Difficult to Remove (1528); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a lesion in the right brachial artery. A 9x60mm armada 35 balloon catheter was prepped per the instructions for use. The balloon catheter was advanced to the lesion; however, the balloon ruptured and separated during first inflation at 12 atmospheres. Resistance removing the device off the guide wire was felt. The procedure was successfully completed with a new 9x60mm armada 35 balloon catheter. There was no clinically significant delay in the procedure and no adverse patient effects. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual inspection and scanning electron microscopy (sem) analysis was performed on the returned device. The reported balloon rupture, difficulty removing from the guide wire and separation were confirmed. The investigation determined the reported difficulties were likely due to case circumstances. 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 the reported difficulties were likely 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 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 Key6491277
MDR Text Key72947714
Report Number2024168-2017-03161
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,Followup
Report Date 05/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberB1090-060
Device Lot Number51120G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer03/27/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/23/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2015
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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