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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 B2120-040
Device Problems Material Rupture (1546); Torn Material (3024)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/11/2018
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. Evaluation summary: a visual inspection was performed on the returned device. The reported balloon rupture and balloon tear were confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lots that would have contributed to this event. Additionally, a review of the complaint history identified no other similar incidents reported from this lot or relabeled lots. The investigation was unable to determine a conclusive cause for the reported balloon rupture. The balloon tear appears to be related to operational context of the procedure. 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 during a procedure of the heavily tortuous, heavily calcified, eccentric, de novo, mid common iliac, the armada 35 balloon was inflated at 10 atmospheres (atm), but ruptured. The device was removed from the anatomy without reported issue. There was no reported adverse patient effect or a clinically significant delay in the procedure. 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 Key7367529
MDR Text Key103529778
Report Number2024168-2018-02138
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K111899
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
Report Date 03/23/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/23/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Catalogue NumberB2120-040
Device Lot Number40904G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/01/2014
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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