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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 AB14W020210150
Device Problems Burst Container or Vessel (1074); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/04/2022
Event Type  malfunction  
Event Description
Physician was attempting to use a nanocross pta balloon catheter along with a non-medtronic 6fr sheath during procedure to treat a severely calcified lesion in the mid anterior tibial artery (ata). The vessel was little tortuous. The vessel diameter and lesion length were 2mm and 210mm respectively. No embolic protection was used. A non-medtronic inflation device was used for the balloon inflation. A standard mix was used for inflation fluid. There was no damage noted to packaging. There was no issue noted when removing the device from hoop/tray. The device was prepped per ifu with no issues identified. It was reported that during balloon inflation a longitudinal burst occurred at nominal pressure. The device did not pass through a previously deployed stent. There was resistance encountered when advancing device with excessive force used during delivery. Physician used another balloon to complete the procedure. There was no patient injury reported.
 
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 Key13478484
MDR Text Key291379160
Report Number2183870-2022-00046
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 05/27/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W020210150
Device Catalogue NumberAB14W020210150
Device Lot NumberB041497
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received05/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/16/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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