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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 AB14W025210150
Device Problem Burst Container or Vessel (1074)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/28/2022
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 nanocross pta balloon along with 6fr sheath and non-medtronic 0. 014" guidewire during procedure to treat to treat a severely calcified lesion in the left mid posterior tibial artery (pta) with chronic total occlusion (cto-100%). The vessel was moderately tortuous. The vessel diameter and lesion length are 2. 5mm and 280mm respectively. A non-medtronic inflation device was used for balloon inflation. A 50/50 contrast 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 longitudinal balloon burst occurred at 8atm during balloon inflation. Event occurred on the first inflation. All fragments of the balloon were retrieved. The device did not pass through a previously deployed stent. There was no resistance encountered when advancing the device. It was reported that the nanocross tapered balloon was inflated in the patient to 8 atms and ruptured on that i nflation. Balloon and catheter was removed from patient with no issues. Another nanocross tapered balloon was opened and used without incident. 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
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13993769
MDR Text Key288470934
Report Number2183870-2022-00118
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00763000109721
UDI-Public00763000109721
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 06/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberAB14W025210150
Device Catalogue NumberAB14W025210150
Device Lot NumberB217446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received06/17/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured06/07/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No

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