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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 AB14W050120150
Device Problems Burst Container or Vessel (1074); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); Patient Problem/Medical Problem (2688)
Event Date 02/01/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
It was reported that the physician intended to use a 5x120x150 nanocross elite pta balloon to treat a slightly calcified slightly tortuous lesion in the proximal superficial femoral artery(sfa). The artery diameter and lesion length were reported to be 5mm & 20mm, respectively. There was no damage noted to the packaging and there were no issues noted when removing the device from the tray/hoop. The device was prepped without issue. No embolic protection was used. The device was inflated with a non-medtronic inflation device. The device did pass through a previously deployed stent and no resistance was encountered on advancing the device to the target lesion. There were wire movement issues reported and the guidewire locked up during the procedure. The nanocross elite pta balloon was reported to have ruptured during inflation at 14atm. The procedure was completed using a sheath and the balloon was removed. No patient injury was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information received a non-medtronic guidewire and sheath were used during the procedure. Patient had surgery to retrieve the balloon fragments from the common femoral artery. 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 Key8330440
MDR Text Key138995167
Report Number2183870-2019-00068
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 05/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/09/2021
Device Catalogue NumberAB14W050120150
Device Lot NumberA721353
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 Received04/29/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/10/2018
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: 02/12/2019 Patient Sequence Number: 1
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