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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER

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ABBOTT VASCULAR ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B1080-040
Device Problem Device Damaged by Another Device (2915)
Patient Problem Insufficient Information (4580)
Event Date 03/10/2021
Event Type  malfunction  
Manufacturer Narrative
The device was not returned for evaluation. The lot history record (lhr) for this product could not be reviewed and a similar complaint query could not be performed because the product was not returned for evaluation and the lot number was not reported. Based on the information provided, a conclusive cause for the reported difficulties could not be determined. It may be possible that the absolute pro stent was narrowed in the mid area or the armada 35 balloon was inflated to a diameter larger than that the absolute pro stent diameter resulting in the stent fracture; however, this could not be confirmed. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device. The abs pro vascular stent referenced is filed under a separate medwatch report number.
 
Event Description
It was reported the procedure was to treat an arteriovenous (av) fistula. The absolute pro was implanted in the fistula, without issue, and post dilated with an 8x40mm armada 35 balloon dilatation catheter (bdc). After post dilatation, the stent was noted to be fractured in the mid area. The vessel was opened up after post dilatation with the balloon; therefore, no additional treatment was needed and the fractured stent was left as is. The procedure was complete at this time. There were no adverse patient effects and no 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)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR COSTA RICA, REG # 3009564766
52 calle 3 b31 coyol free zone
el coyol alajuela
CS
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key11606031
MDR Text Key244617208
Report Number2024168-2021-02654
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
Type of Report Initial
Report Date 04/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB1080-040
Device Catalogue NumberB1080-040
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 Received03/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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