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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 A2025-120
Device Problems Deformation Due to Compressive Stress (2889); Material Split, Cut or Torn (4008)
Patient Problem No Patient Involvement (2645)
Event Date 06/12/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. Visual inspection was performed on the returned device. The reported kink was confirmed. Additionally, there was a tear in the inner member at the kink. A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint. Additionally, a review of the complaint history of the reported lot revealed no other similar incidents. Based on the information provided, the reported difficulties appear to be due to operational context. It is likely that during the attempt to load the armada 14 over the guide wire, the shaft kinked resulting in the proximal end of the guide wire puncturing the inner member. There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

 
Event Description

It was reported that during preparation of a 2. 5x120 mm armada percutaneous transluminal (pta) catheter, a kink in the shaft was noted right across from the distal marker. The device was not used. There was no patient involvement. There was no reported significant delay in the procedure. Return device analysis revealed there was a tear/hole in the inner member at the kink. No additional information was provided.

 
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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
Manufacturer (Section G)
CLONMEL, IRELAND REG# 9616693
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key7724510
MDR Text Key115213866
Report Number2024168-2018-05805
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeNL
PMA/PMN NumberK102705
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 07/26/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/26/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberA2025-120
Device LOT Number8013041
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/13/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/19/2018
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured01/01/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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