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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER

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AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013468-040
Device Problem Unsealed Device Packaging (1444)
Patient Problem No Patient Involvement (2645)
Event Date 06/19/2018
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 relevant information.
 
Event Description
It was reported that during unpacking of a 5. 0 x 40 mm armada 18 balloon catheter, prior to opening the pouch it was observed that the seal was incomplete. A corner of the pouch was not sealed and a decision was made to not use the balloon catheter. The procedure was successfully completed with an unspecified armada balloon catheter. There was no patient involvement 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 unpackaged device packaging and sterility breach was confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot and relabeled lot that could have contributed to this event. Additionally, a review of the complaint history revealed no other similar incidents reported for this lot. The investigation was unable to determine a conclusive cause for the reported unpackaged device packaging and sterility breach. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
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Brand NameARMADA 18 PTA CATHETER
Type of DevicePERIPHERAL DILATATION CATHETER
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
MDR Report Key7675924
MDR Text Key113626258
Report Number2024168-2018-05228
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
PMA/PMN Number
K151317
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 08/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2021
Device Catalogue Number1013468-040
Device Lot Number7080141
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/26/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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