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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 B2080-040
Device Problems Unsealed Device Packaging (1444); Component Missing (2306)
Patient Problem No Patient Involvement (2645)
Event Date 06/22/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The device is expected to be returned for evaluation. It has not yet been received. A follow up report will be submitted with all additional relevant information.
 
Event Description
It was reported that after selecting an 8. 0 x 40mm armada 35 for use in the procedure, it was observed that the sterilized (clear) pouch of the device had been opened (not sealed). Additionally, the device was missing from the sterile (clear) pouch. There was no patient involvement. Another armada device was used to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Visual inspection was performed on the returned product pouch. The reported unsealed device packaging and missing component (device) were confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that could have contributed to this event. Additionally, a review of the complaint history of the reported lot revealed no other incidents reported for this lot. The investigation determined the reported unsealed device packaging and missing component (device) appears to be related to a potential product quality issue. The issue is being addressed per internal operating procedures. Abbott vascular will continue to trend the performance of these devices.
 
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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
MDR Report Key7690252
MDR Text Key114053758
Report Number2024168-2018-05454
Device Sequence Number1
Product Code LIT
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,distri
Remedial Action Other
Type of Report Initial,Followup
Report Date 08/02/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/31/2020
Device Catalogue NumberB2080-040
Device Lot Number70522G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/30/2018
Is This a Reprocessed and Reused Single-Use Device? No

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