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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 B2070-040
Device Problems Off-Label Use (1494); Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/19/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. (b)(4). The device was not returned for analysis. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history identified no indication of a lot specific product issue. It should be noted that the armada 35 instruction for use states: the device is intended for dilatation of lesions in the renal, iliac, femoral, popliteal, tibial, and peroneal arteries and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. It could not be determined if the off-label use contributed to the balloon rupture. The investigation determined that the reported balloon rupture was likely due to case circumstances, as it is likely that the rupture occurred due to interaction with the heavily calcified lesion causing damage to the outer surface of the balloon material. 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 the procedure was to treat a heavily calcified lesion in the left subclavian artery. The 7. 0x40mm armada 35 balloon catheter was advanced to the lesion with no resistance noted. During the first inflation, the balloon ruptured at the rated burst pressure (rbp) of 15 atmospheres (atm). The device was removed with no issue and a stent was placed to complete the procedure. There was no clinically significant delay in the procedure and no adverse patient effects. 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 Key7897789
MDR Text Key121015977
Report Number2024168-2018-07320
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648155352
UDI-Public08717648155352
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 09/21/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/21/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberB2070-040
Device Lot Number80221G1
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 Received09/19/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2018
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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