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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 AB14W060150150
Device Problems Deflation Problem (1149); Inflation Problem (1310)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/08/2022
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use the nanocross elite pta balloon during procedure to treat moderately calcified lesion in the proximal left superficial femoral artery(sfa). The vessel had little tortuosity and exhibited 80% stenosis. The artery diameter was 6mm and lesion length was 60mm. A 6fr sheath and non-medtronic guidewire were used. The balloon was inflated with a non-medtronic inflation device. There was no damage noted to packaging, i. E. , shelf carton, hoop/tray and no issues noted when removing the device from the hoop/tray. No damage was noted to the balloon catheter. No kinks were noted in balloon catheter or wire. It was reported that both inflation and deflation issues were noted. Balloon partially inflated then wouldn¿t deflate. There were balloon inflation difficulties at 8atm. It was reported that there were balloon deflation difficulties. Device would not deflate at the lesion site. Deflation issues noted following first inflation. Deflation issues noted during subsequent inflation. The device did not pass through a previously deployed stent. No resistance was encountered when advancing the device. It took 15 minutes of backward pressure to get balloon deflated enough to go through the sheath. No patient injury.
 
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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 Key14117274
MDR Text Key289327660
Report Number2183870-2022-00142
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
Report Date 04/15/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W060150150
Device Catalogue NumberAB14W060150150
Device Lot NumberB338824
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/08/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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