• 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 35 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 35 PTA CATHETER PERIPHERAL DILATATION CATHETER Back to Search Results
Catalog Number B2050-060
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Folded (2630)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information. The device was returned for analysis and abbott vascular (av) confirmed the reported difficulty in deflating the balloon. A review of the complaint handling database found no similar incidents from this lot. Av conducted a thorough root cause analysis and determined the deflation issue is potentially related to manufacturing. The issue is being addressed per internal operating procedures. Av will continue to trend the performance of these devices.
 
Event Description
It was reported that the patient underwent a peripheral procedure, treating a target lesion in the right iliac artery. The armada 35 dilatation catheter was advanced to the target lesion and was inflated 1 time, to 18 atmospheres (atm) and deflated without issue. The device was inflated a second time, to 18 atm, but deflated slowly. Difficulty was noted removing the device, and upon removal, the balloon was noted to have bunched up towards the tip of the device. A second unspecified dilatation catheter was used, and was followed by stenting. There was no adverse patient effect and no clinically significant delay. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameARMADA 35 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)
EL COYOL, COSTA RICA REG# 3009031392
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 Key7216017
MDR Text Key98412974
Report Number2024168-2018-00557
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K111899
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 01/24/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/24/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2019
Device Catalogue NumberB2050-060
Device Lot Number60331G1
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/11/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-