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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
Model Number AB14W050040150
Device Problem Detachment of Device or Device Component (2907)
Patient Problem Injury (2348)
Event Date 11/02/2020
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician intended to use a nanocross elite pta balloon with a non-medtronic 7fr sheath and non-medtronic guidewire during treatment of a 40mm plaque lesion in the patient¿s proximal left superficial femoral artery (sfa). Artery diameter reported as 9mm. Slight vessel calcification and tortuosity are reported. No damage was noted to the product packaging prior to sue. No issues were noted when removing the device from the packaging. Ifu was followed and the device was prepped without issue. Following use of the balloon, it is reported that excessive force was used during withdrawal of the device as the physician felt resistance at the sheath and tugged. This resulted in a detachment at the tip with part of the balloon remaining in the sheath. The fragment dislodged at the access site as everything was removed. Access was gained on the opposite side and a snare was used for removal of the detached portion. No further injury reported.
 
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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 Key10815678
MDR Text Key215470520
Report Number2183870-2020-00379
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
Report Date 03/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W050040150
Device Catalogue NumberAB14W050040150
Device Lot NumberB071112
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/20/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/16/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/17/2020
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: 11/10/2020 Patient Sequence Number: 1
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