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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, TRANSLUMINA

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COVIDIEN NANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number AB14W060200150
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 12/14/2021
Event Type  Injury  
Event Description
Physician was attempting to use the nanocross elite pta balloon catheter during procedure to treat little calcified lesion in the mid superficial femoral artery (sfa). The vessel had no tortuosity. The artery diameter was 5. 5 mm. A non medtronic 6fr sheath and 0. 014'' guidewire were used. The device was inflated with a non medtronic inflation device. Saline/contrast inflation fluid was used. There was no damage noted to packaging and no issues when removing the device from the hoop/tray. The device was prepped with no issues. It was reported that there was a balloon burst/leak at the luer/hub during the first balloon inflation at 4-5 atm. All fragments of the balloon were retrieved. The device detached/cracked/fractured at balloon during removal from patient after inflations. A non medtronic snare was used to remove the detached portion. The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device. After the balloon was removed with snare the procedure was completed with completion angiograms to confirm satisfactory results. No patient injury.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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Brand NameNANOCROSS ELITE 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer (Section G)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13018574
MDR Text Key284115373
Report Number2183870-2021-00460
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup
Report Date 05/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W060200150
Device Catalogue NumberAB14W060200150
Device Lot NumberB289579
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/29/2021
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: 12/16/2021 Patient Sequence Number: 1
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