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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR ARMADA 35 OTW PERIPHERAL DILATATION CATHETER Back to Search Results
Model Number B2040-100
Device Problem Contamination /Decontamination Problem (2895)
Patient Problem No Patient Involvement (2645)
Event Date 03/10/2020
Event Type  malfunction  
Manufacturer Narrative
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 a 4x100mm armada 35 percutaneous transluminal angioplasty (pta) was received by the customer with blood on the outside packaging. The device was not used and there was no patient involvement. No additional information was provided.
 
Manufacturer Narrative
The device was returned and 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. The noted crushed portion on the bottom right-hand corner of the chipboard box may have occurred during transport for return of the device. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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Brand NameARMADA 35 OTW
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 Key9916678
MDR Text Key186370076
Report Number2024168-2020-03272
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/02/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2021
Device Model NumberB2040-100
Device Catalogue NumberB2040-100
Device Lot Number80511G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/13/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/11/2018
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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