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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
Catalog Number AB14W050040150
Device Problems Entrapment of Device (1212); Fracture (1260); Device Damaged by Another Device (2915); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/18/2019
Event Type  Injury  
Manufacturer Narrative

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

 
Event Description

Physician used a nanocross elite with a 6fr non-medtronic sheath and nitrex wire during treatment of a 150mm, calcified cto (chronic total occlusion-100%) in the patient¿s mid right superficial femoral artery (sfa) of diameter 6mm. Moderate vessel tortuosity and severe calcification are reported. Ifu was followed. No issues noted to packaging prior to use. No issues noted when removing he device from the packaging. The device was prepped without issue. A non-medtronic inflation device was used with heparinized saline and contrast for balloon inflation. The device was passed through a previously deployed stent without resistance. It is reported that on the second inflation when the balloon was inflated to 14atm, the device became caught on a stent. Resistance was encountered during withdrawal and excessive force was used. The balloon is reported to have fractured. A snare was used to remove the detached balloon fragment from the patient. No patient injury reported.

 
Manufacturer Narrative

Additional information: the device passed through a previously deployed 6x150 everflex stent without resistance. There were no issues caused to the stent. No further patient injury was reported for this event. 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, 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 Key9502624
MDR Text Key172441896
Report Number2183870-2019-00597
Device Sequence Number1
Product Code LIT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK132777
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 03/09/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/20/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberAB14W050040150
Device LOT NumberA839903
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 Received03/06/2020
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured05/31/2019
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: 12/20/2019 Patient Sequence Number: 1
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