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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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COVIDIEN POWERCROSS 018 CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL Back to Search Results
Catalog Number AB18W060060150
Device Problem Device Expiration Issue (1216)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 04/10/2017
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
A good faith effort will be made to obtain the applicable information relevant to the report. If information is provided in the future, a supplemental report will be issued.
 
Event Description
The physician used one powercross balloon to treat a lesion in an unknown vessel. The device was removed from the packaging and inspected with no issues noted. The device was used successfully with no problems. It was reported that the device was used approximately one month post expiry. No patient injury was reported.
 
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Brand NamePOWERCROSS 018
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 Key6607710
MDR Text Key100521931
Report Number2183870-2017-00235
Device Sequence Number1
Product Code LIT
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K093286
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 05/05/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/02/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/04/2017
Device Catalogue NumberAB18W060060150
Device Lot NumberA052147
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 Received05/05/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured02/03/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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