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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 AB14W020040150
Device Problems Burst Container or Vessel (1074); Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/28/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician attempted to use a nanocross pta balloon during treatment of a calcified lesion in the patient¿s anterior tibial artery. There was no damage noted to packaging, i. E. Shelf carton, hoop/tray. No issues were noted when removing the device from the hoop/tray. The device was prepped as per ifu without issue. A balloon burst below nominal pressure is reported. No fragments remained in the patient. The device was used 4 days past expiration. A replacement medtronic balloon was used to complete the procedure. 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 Key12245050
MDR Text Key264153837
Report Number2183870-2021-00265
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K082854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 08/26/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/29/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/24/2021
Device Model NumberAB14W020040150
Device Catalogue NumberAB14W020040150
Device Lot NumberA666442
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/28/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/25/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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