• 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 B2040-040
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/07/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The supera device referenced is filed under a separate medwatch manufacturer report reference number.The device was received.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 calcified mid left superficial femoral artery (sfa).The vessel diameter was 4 mm.A 4x40 mm armada 35 pta balloon catheter failed to inflate and leaking was noted at the hub.Reportedly, pre-dilatation was performed with a 4x40 mm armada 35 to 4.5mm with no waist or narrowing noted.A 4x80 mm supera stent did not deploy correctly 2 cm from the proximal end, twisted.The supera stent was deployed to nominal except for tight narrowing.Reportedly, there was no resistance noted with the thumbslide during deployment of the supera stent.Several attempts to post dilate the stent with a 2.5x40 mm armada 18, then a 4x40 mm armada 18, then a 5x20 mm armada 18 and finally, a 4.5x15 mm nc trek balloon dilatation catheter resolved the issue.However, the final run showed that the sfa had thrombosed.There was no reported clinically significant delay in the procedure.The patient was treated overnight with thrombolysis and discharged from the hospital.No additional information was provided.
 
Manufacturer Narrative
(b)(4).Evaluation summary: visual and functional inspections were performed on the returned device.The leak was not confirmed.It may be possible that there was a faulty connection with the syringe or inflation device, resulting in the inflation issue and leak; however, this could not be confirmed.The investigation was unable to determine a conclusive cause for the reported inflation issue and leak.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot.Additionally, a review of the complaint history of the reported lot revealed no other incidents.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
ARMADA 35 PTA CATHETER
Type of Device
PERIPHERAL 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 Key6215686
MDR Text Key63832145
Report Number2024168-2016-09389
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeNZ
PMA/PMN Number
K111899
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Health Professional
Remedial Action Other
Type of Report Initial,Followup
Report Date 01/31/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2019
Device Catalogue NumberB2040-040
Device Lot Number60618G1
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer12/13/2016
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/07/2016
Initial Date FDA Received12/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received01/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age62 YR
-
-