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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 AB14W060040150
Device Problems Burst Container or Vessel (1074); Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 06/14/2021
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use nanocross pta balloon along with non-medtronic 6fr sheath and 0. 014" guidewire during procedure to treat a severely calcified lesion on the proximal, mid and distal superficial femoral artery (sfa) with 80-90% stenosis. The vessel was moderately tortuous. The vessel diameter and lesion length are 6-7mm and 30mm respectively. No embolic protection was used. Inflation device was used for balloon inflation. Hep saline was used for inflation fluid. There was no damage noted to packaging. There was no issue noted when removing the device from the hoop/tray. The device was prepped per the ifu with no issues identified. During single inflation, balloon burst occurred at 12atm. All fragments of the balloon were retrieved. The balloon did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. During withdrawal excessive force was used. Physician aborted case after balloon remained partially in the body to be removed. Patient was ok post op no events related to the procedure. It was reported that contralateral access was used when treating a 80-90% stenotic right common femoral artery using atherectomy thx-svc followed by angioplasty of the sfa using a nanocross 6x40x150 which burst before rated pressure. In the process of trying to remove the balloon catheter physician was able to pull into the non-medtronic 6f sheath, where it got stuck. Struggling to remove it physician tried pulling as one unit (6f sheath, 0. 014 wire, and the balloon catheter) with no success. Balloon detached from the catheter was able to remove everything but the actual balloon which remained inside of the left common femoral artery. Losing all access, balloon still in the artery, physician needed to do a cut down, opened up the artery in order to remove the foreign body. Everything went well, patient was safely removed from the ir and went home no complications or any other related events.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12017124
MDR Text Key256777781
Report Number2183870-2021-00214
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00763000110406
UDI-Public00763000110406
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 07/22/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/17/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W060040150
Device Catalogue NumberAB14W060040150
Device Lot NumberB195137
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/22/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/23/2021
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: 06/17/2021 Patient Sequence Number: 1
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