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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 AB14W035080150
Device Problem Burst Container or Vessel (1074)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 07/05/2019
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 was using a nanocross pta balloon to treat a lesion in the mid right popliteal artery. The lesion was described as severely calcified, with slight tortuousity and about 7cm in length in a vessel described as approx. 3. 5-4mm in diameter. 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. A 6fr non-medtronic sheath and a 0. 014 non-medtronic guidewire were used with no embolic protection. It was reported that during the second inflation of the balloon to 10atm, the balloon burst. Most fragments of the balloon were retrieved by snare and one fragment was caged with a stent. No patient injury was reported.
 
Manufacturer Narrative
Additional information: a non-medtronic stent which had to be deployed in an unintended area was used to cage the balloon fragments to the vessel wall. If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
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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 Key8771315
MDR Text Key150403717
Report Number2183870-2019-00363
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082854
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 10/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/09/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2022
Device Catalogue NumberAB14W035080150
Device Lot NumberA834198
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 Received10/03/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/20/2019
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: 07/09/2019 Patient Sequence Number: 1
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