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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

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COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB14W050200150
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems Injury (2348); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/26/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a nanocross elite pta balloon during treatment of a calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa). Severe vessel calcification is reported. There was no damage noted when removing the device from the product packaging. No issues were noted when removing the device from the hoop/tray. Ifu was followed and the device was prepped without issue. The device was not passed through a previously deployed stent. No resistance was noted during advancement. Removal difficulties are reported. It is reported after inflation of the balloon to 10atm for 2 minutes, the balloon was repositioned and again inflated to 10atm. The balloon is reported to have ruptured with the balloon shaft stripping off the balloon. On attempt to remove the device, a section of the balloon separated from the catheter. Antegrade access was gained and a snare was used to retrieve the balloon in the popliteal. The patient is reported to be fine without any reported issues. No further injury re ported.
 
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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 Key10790980
MDR Text Key214752841
Report Number2183870-2020-00360
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 02/19/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W050200150
Device Catalogue NumberAB14W050200150
Device Lot NumberB061991
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/16/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/18/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/30/2020
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: 11/05/2020 Patient Sequence Number: 1
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