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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 AB14W035210150
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/11/2019
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was using a nanocross pta balloon with a non medtronic 6fr sheath and guide wire to treat a moderately calcified fibrous lesion in the left proximal posterior tibial artery with a 65% stenosis. The vessel diameter and lesion length are 2. 3mm and 80mm respectively. The vessel is little tortuous. The contract and saline was used to inflate the device. No damage noted to packaging. No issues noted when removing the device the hoop/tray. The device was prepped per ifu. It was reported that the balloon would not deflate at the lesion site. The flow was impeded in vessel. The deflation issue was noted during subsequent inflation. The balloon delivery system was deformed - stretching and twisting. Physician also experienced difficulty removing the device following the balloon inflation. The balloon was eventually deflated enough to be pulled out with the sheath. There was no resistance encountered when advancing the device and no excessive force used. There was no patient injury reported.
 
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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 Key9005850
MDR Text Key194677725
Report Number2183870-2019-00438
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,Followup
Report Date 12/10/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/12/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB14W035210150
Device Lot NumberA876381
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/23/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/09/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/03/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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