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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, TRANSLUMINA

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COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINA Back to Search Results
Model Number AB14W025120150
Device Problems Burst Container or Vessel (1074); Entrapment of Device (1212); Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problems Obstruction/Occlusion (2422); Device Embedded In Tissue or Plaque (3165)
Event Date 12/06/2021
Event Type  Injury  
Event Description
Physician was attempting to use the nanocross balloon catheter during procedure to treat severely calcified lesion in the mid and proximal right tibial/popliteal trunk (tpt) and peroneal artery. The vessel had no tortuosity and exhibited 80% stenosis. The artery diameter was 2. 5mm and lesion length was 40-50mm. A non-medtronic 7fr sheath and non-medtronic 0. 014'' guidewire were used. The balloon was inflated with a non-medtronic inflation device. Inflation fluid of 50-50 contrast and saline was used. There was no damage noted to packaging and no issues when removing the device from the hoop/tray. The device was prepped per the ifu with no issues. The balloon did not pass through a previously-deployed stent. There was no stent present in the vessel bed in the patient's right leg. It was reported that guidewire lock-up occurred during procedure in tandem with a longitudinal balloon burst at 8atm. The balloon was used to dilate a cto anterior tibial artery multiple times successfully and when redirected to tibial peroneal trunk artery the balloon ruptured on first inflation. All fragments were not retrieved. The physician made multiple attempts to retrieve remaining parts of balloon(distal catheter tip, distal balloon marker and some residual balloon material that separated from the balloon catheter) us ing a 4mm gooseneck snare but was unsuccessful. The detached portions remain in the patient as were difficult to remove. Resistance was encountered advancing the device and excessive force was used during delivery and withdrawal. Prior to intervention, anterior tibial artery was cto, proximal and mid tpt was heavily calcified and diseased, posterior tibial artery was cto, peroneal artery was distally occluded. After multiple unsuccessful tries with gooseneck snare, post angiogram showed anterior tibial artery was patent (it was angioplastied with same 2. 5 x 120 x 150 nanocross earlier). The unsuccessful use of the snare was due to diffuse disease and heavy calcium present at the location, where the foreign object was dislodged, unable to pass snare catheter through occluded artery in order to retrieve the foreign object. The snare was removed successfully from the patient's body without any incident and all intact. Tpt was now sub occluded with balloon marker and distal tip remaining inside. No additional procedure was performed after the incident. No other upcoming procedures are scheduled for the patient, but the patient is scheduled for a follow up appointment. Patient removed to recovery room and is reported to be doing well.
 
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, 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13008948
MDR Text Key282264907
Report Number2183870-2021-00457
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 Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/21/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W025120150
Device Catalogue NumberAB14W025120150
Device Lot NumberB295439
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/16/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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