• 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 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 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB14W040100150
Device Problem Burst Container or Vessel (1074)
Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)
Event Date 08/08/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was using a nano cross pta balloon catheter to treat the proximal, mid and distal right common iliac artery with a non-medtronic 6fr sheath and guide wire. The device was prepped per ifu with no issues identified. The balloon was inflated using a non-medtronic inflation device. The vessel was moderately tortuous and the chronic totally occluded lesion was severely calcified. It was reported that a longitudinal burst occurred at 6atm during inflation. There was difficulty removing the catheter and the balloon catheter was stretched out. It was reported that majority of the balloon remains in the patient and surgery is planned at a later date to remove remaining fragments.
 
Manufacturer Narrative
Device evaluation the nanocross elite was inspected and found the distal end was fractured off. The balloon showed a radial bust at the proximal location of the balloon. The blue gw lumen measured approximately 56cm out from the radial burst location. A kink to the catheter shaft was noted at approximately 160cm from the distal end. The working length was approximately 195cm. The marker bands were no observed. It is likely the segment of the catheter where the marker bands were attached fractured off. The distal segment of the catheter which had fractured off was not returned. The distal tip of the gw catheter lumen was inspected under microscope. The distal tip showed a ductile type fracture face with noted stretching. The radial balloon burst area was inspected under microscope. The observed kink was inspected under microscope and observed a blue gw lumen was compressed. A 0. 035" guidewire was loaded through the returned 6f sheath in efforts to see if the distal segment of the catheter was lodged within the sheath. There was no sign of debris stuck inside the introducer lumen. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: no snare attempt was made. The 6x10 sheath was removed as the physician believed the balloon fragment remained in the sheath. The fragment was not in the sheath, so an attempt was made to bareback a trailblazer over the 014 wire unsuccessfully. Pre-dilation was then performed to attempt to advance a 7x25 sheath into the iliac. Due to heavy calcification from the iliac down to the common femoral, it was difficult to get the sheath in. The balloon fragment was located in the right common iliac patient had surgery to remove the balloon fragment. Endarterectomy of the cfa and bypass of the iliac also performed. Patient is stable and recovering from surgery. 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 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 Key8878250
MDR Text Key153796773
Report Number2183870-2019-00397
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/22/2022
Device Catalogue NumberAB14W040100150
Device Lot NumberA836690
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/23/2019
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: 08/09/2019 Patient Sequence Number: 1
-
-