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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
Catalog Number AB14W020150150
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician was attempting to use a nanocross pta balloon catheter along with non-medtronic 5fr sheath and 300cm guidewire during procedure to treat a moderately calcified lesion in he distal posterior tibial artery (pta). The vessel was moderately calcified. The vessel diameter and lesion length are 3mm and 350mm respectively. No embolic protection was used. A non-medtronic device was used for balloon inflation. 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 delivery through the vessel the balloon broke and the detached portion remained in the patient. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. There was no attempt made to inflate the balloon when the break was made. The balloon catheter broke. All components were successfully removed from patient. There was no intervention required for removal of device. There was no vessel damage noted. Physician completed procedure with another nanocross of the same size. There was no patient injury reported.
 
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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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12524389
MDR Text Key273122887
Report Number2183870-2021-00353
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeCI
PMA/PMN Number
K082854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/24/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAB14W020150150
Device Lot NumberB108626
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/18/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured10/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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