• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

AV-TEMECULA-CT ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number 1013470-150
Device Problems Deflation Problem (1149); Failure to Fold (1255); Difficult to Remove (1528); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/25/2019
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. The investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a heavily calcified lesion in the superficial femoral artery (sfa). The 6. 0x150mm otw armada 18 balloon dilatation catheter was advanced to the lesion and inflated one time to 10 atmospheres (atm). An attempt was made to deflate the balloon however it would not completely deflate. The armada was removed however met resistance at the 6fr introducer sheath and the balloon bunched and tore. The armada, guiding catheter and sheath were removed as a single unit. The procedure was completed with a new balloon catheter. Although this issue caused a delay in the procedure, the delay did not result in adverse patient sequelae; therefore is not considered clinically significant. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key8347522
MDR Text Key136609094
Report Number2024168-2019-01178
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K151317
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,Followup
Report Date 02/21/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date07/31/2020
Device Catalogue Number1013470-150
Device Lot Number7021041
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer02/08/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2019
Was Device Evaluated by Manufacturer? Yes
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

-
-