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U.S. Department of Health and Human Services

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

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COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB14W040080150
Device Problem Device Dislodged or Dislocated
Event Date 10/18/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

 
Event Description

It was reported that the physician was attempting to use a nanocross to treat a severely calcified cto (chronic total occlusion) lesion in the mid left superficial femoral artery(sfa). The artery diameter and lesion length were 6mm and 350mm respectively. Physician used a non-medtronic 6fr 11cm sheath, a non-medtronic guidewire and a non-medtronic inflation device. 50/50 saline/contrast mixture was used. The ifu was followed and the device was prepped without issue. The device passed through a previously deployed stent. Resistance was reported when advancing the device. Excessive force was used during delivery and withdrawal. It was reported that the physician had difficulty advancing the balloon through the deployed stent as the artery was heavily calcified. After inflating the balloon in the stent, to open up the artery, the calcified vessel recoiled and applied pressure to the balloon making it difficult to withdraw from the stented area and the patient. The physician applied force in an attempt to remove the balloon catheter, it came free but was hard to pull into the sheath. Additional force was applied, the balloon catheter came out but was lodged in the distal end of the sheath. When the sheath was removed from the patient the balloon came out with the sheath and was removed from the patient. Hemostasis was achieved and the patient experienced no adverse outcome due to the balloon dislodgment from the catheter.

 
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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 Key8063590
Report Number2183870-2018-00510
Device Sequence Number1
Product CodeLIT
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAB14W040080150
Device LOT NumberA449038
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/18/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured04/21/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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