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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 1013464-060
Device Problems Difficult to Remove (1528); Deformation Due to Compressive Stress (2889); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/21/2018
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 not returned for analysis. 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 lots revealed no other incidents. The investigation determined the reported difficulties were due to case circumstances. The difficulty advancing and removing the guide wire through the armada 18 was due to the kinked tip which occurred due to the anatomy. 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 the procedure was to treat a moderately calcified proximal anterior tibial artery. A 2. 5 x 60 mm armada 18 balloon dilatation catheter (bdc) was used; however, the tip of the catheter became kinked due to the anatomy. Therefore, a non-abbott guide wire could not advance through the bdc due to the kink. Both devices were then removed as a single unit as the armada bdc met resistance with the guide wire. A csi procedure was then performed with another unspecified bdc to successfully complete the procedure. There were no adverse patient effects and no clinically significant delay in the procedure. No additional information was provided.

 
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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
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 Key7872758
MDR Text Key120136602
Report Number2024168-2018-07142
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK151317
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 09/13/2018
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received09/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date07/31/2020
Device Catalogue Number1013464-060
Device LOT Number7021741
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/21/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured02/01/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 09/13/2018 Patient Sequence Number: 1
Treatment
GUIDE WIRE: VIPER
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