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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 A2020-020
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 04/02/2018
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 before patient use, the armada packing was removed from the outer box without reported issue. Once brought into the procedure area, it was noticed that the packaging had a hole in it. The device sterility was questioned and the device was set aside ad not used in the patient. There was no patient involvement. There was no additional information provided regarding this device issue.
 
Manufacturer Narrative
(b)(4). Evaluation summary: a visual inspection was performed on the returned device. The reported balloon damage was confirmed. The damage to the pouch was not verified as the packaging was not returned. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. A query of the complaint database for the reported lot was performed and revealed no other incidents reported. The investigation determined the reported difficulties appear to be related to circumstances of the procedure. Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
Subsequent to the previously filed medwatch report, the additional information was obtained: reportedly, this was a busy case and following the procedure, the device was noted on the preparation table with a crimped balloon. It is unknown whether or not the device was used in the patient.
 
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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 Key7470609
MDR Text Key106896092
Report Number2024168-2018-03150
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 05/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2021
Device Catalogue NumberA2020-020
Device Lot Number8021341
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer04/24/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/18/2018
Is This a Reprocessed and Reused Single-Use Device? No

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