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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 B1070-040
Device Problem Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)
Event Date 06/12/2020
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 during preparation of the armada 35, during filling with contrast, a leak was noticed in the shaft just in front of the proximal part of balloon.The device was not used.There was no patient involvement and no clinically significant delay in procedure.No additional information was provided.
 
Event Description
Subsequent to the previously filed report, additional information received stated the leak was noticed when inflating the device in the lesion.No additional information was provided.
 
Manufacturer Narrative
Visual, functional and scanning electron microscopy (sem) analysis was performed on the returned device.The reported leak 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 similar complaints reported from this lot.Based on this evaluation, a potential product quality issue has been identified.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6: patient code 2645 - removed.
 
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Brand Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
MDR Report Key10478057
MDR Text Key205151186
Report Number2024168-2020-07269
Device Sequence Number1
Product Code LIT
UDI-Device Identifier08717648154782
UDI-Public08717648154782
Combination Product (y/n)N
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2023
Device Model NumberB1070-040
Device Catalogue NumberB1070-040
Device Lot Number00224G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/31/2020
Initial Date Manufacturer Received 08/11/2020
Initial Date FDA Received09/01/2020
Supplement Dates Manufacturer Received10/23/2020
Supplement Dates FDA Received10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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