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

MAUDE Adverse Event Report: COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

  • 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
 

COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB14W060150150
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 03/13/2018
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician intended to use the nanocross elite to treat a cto in the right proximal popliteal as per ifu. The artery diameter was reported as 6mm. The lesion length was 150mm and described as severely calcified <(>&<)> severely tortuous. A non-medtronic balloon was inflated in the lesion but the balloon burst. The physician then attempted to use the nanocross balloon. When it had crossed the lesion the balloon was inflated to 8-10atm but the balloon burst. The balloon was then deflated but became stuck on the wire on removal. The balloon and the wire were removed as a unit, during which the balloon had stretched and came apart in the sheath. A gooseneck snare was used to remove the blue balloon shaft and part of the balloon. The procedure was finished with a non-medtronic pta balloon.
 
Manufacturer Narrative
Evaluation summary: the nanocross elite was returned in three broken apart segments for evaluation. No ancillary devices were included. Visual inspection: the returned nanocross elite showed a radial fracture/burst of the balloon. The fracture separated the distal and proximal areas of the balloon. The proximal portion of the balloon remained connected to the catheter at the proximal balloon bond. Within this segment, the blue inner was fractured within the catheter. The location of the fracture was approximately 19 cm from the radial fracture face. The working length of this segment was approximately 141. 5cm. Under microscope the balloon showed a traces of dried blood within the balloon material. The fracture face of the of the blue inner within the catheter was flat and showed signs of stretching. The distal segment of the balloon was approximately 5cm. The blue distal tip was present and the distal marker band was identified. The proximal fracture face of balloon was crinkled and showed signs of longitudinal compression. The length of the blue inner was approximately 73cm long. Inspection of the catheter showed buckling of the inner over approximately 12 cm. No marker bands were found during inspection. Functional testing: the balloon was flushed with water. Biological debris within the balloon were cleared. The fracture of the inner occurred at the location of the distal marker band. The radial fracture identified cascaded into further damage to the catheter. If information is provided in the future, a supplemental report will be issued.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameNANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
091708734
MDR Report Key7412846
MDR Text Key104893893
Report Number2183870-2018-00218
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132777
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/12/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/05/2020
Device Catalogue NumberAB14W060150150
Device Lot NumberA565841
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/24/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/06/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/10/2018 Patient Sequence Number: 1
-
-