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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number A2030-120
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 05/11/2018
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 was received. Investigation is not yet complete. A follow up report will be submitted with all relevant information.
 
Event Description
It was reported that during unpacking of the device, a bubble was noted in the middle of the packaging seal on the pouch, the seal was not complete and open at the bubble. When opening the white flap on the pouch, it was easier than normal due to the unsealed portion. The device was set aside and not used. A new armada 14 was used to complete the procedure with no issue. There was no clinically significant delay in the procedure and no patient involvement. No additional information was provided.
 
Manufacturer Narrative
(b)(4). Evaluation summary: visual inspection was performed on the returned device. The cloudy appearance indicated evidence that the seal was previously intact. It is likely that the pouch was inadvertently opened and placed back into the inventory at the account. 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 incidents. The investigation determined that the opened pouch was likely due to previous handling at the account. There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
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Brand NameARMADA 14 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7566273
MDR Text Key110120784
Report Number2024168-2018-04106
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Remedial Action Other
Type of Report Initial,Followup
Report Date 06/11/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberA2030-120
Device Lot Number8022641
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer05/30/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/05/2018
Is This a Reprocessed and Reused Single-Use Device? No

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