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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, TRANSLUMINAL

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COVIDIEN NANOCROSS 0.14 OTW PTA DILATATION CATHETER CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Model Number AB14W020210150
Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/09/2020
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
Physician use a nanocross pta balloon catheter during procedure to treat the pedal artery. Balloon was inflated using an inflating device. It was later reported that the balloon used during procedure was an expired product. No further patient injury reported.
 
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Brand NameNANOCROSS 0.14 OTW PTA DILATATION CATHETER
Type of DeviceCATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
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 
091708734
MDR Report Key10005598
MDR Text Key195419220
Report Number2183870-2020-00131
Device Sequence Number1
Product Code LIT
UDI-Device Identifier00821684066201
UDI-Public00821684066201
Combination Product (y/n)N
Reporter Country CodeSN
PMA/PMN Number
K132777
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 06/15/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/24/2019
Device Model NumberAB14W020210150
Device Catalogue NumberAB14W020210150
Device Lot NumberA333504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/12/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured08/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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