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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 B2060-200
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 01/30/2020
Event Type  malfunction  
Manufacturer Narrative
The other additional vascular device's referenced are being filed under a separate medwatch report number. The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that three armada 35 percutaneous transluminal angioplasty (pta) catheters (5x200mm, 5x20mm, 6x200mm) and two absolute pro self-expanding stent systems (sess) (6x150mm, 6x60mm) were received by the customer with blood marks on the outside packaging. The devices were not used and there was no patient involvement. No additional information was provided.
 
Manufacturer Narrative
Visual inspection and fourier-transform infrared spectroscopy (ftir) analysis were performed on the returned device. The reported complaint was confirmed. 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 of the reported lot revealed no other incidents. Based on the information reviewed and analysis of the returned device, the reported contamination appears to be due to case circumstances. The noted contamination (blood) was likely due to handling of the packaging at the account. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key9727405
MDR Text Key180130492
Report Number2024168-2020-01602
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/27/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/19/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberB2060-200
Device Catalogue NumberB2060-200
Device Lot Number91015G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/03/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/15/2019
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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