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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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COVIDIEN MFG SOLUTIONS S.A. MAHURKAR CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number 8813793009
Device Problems Break (1069); Material Frayed (1262); Difficult to Remove (1528); Difficult to Advance (2920)
Patient Problem No Information (3190)
Event Date 02/21/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, the device had a guide wire issue. The defect was identified while inserting into a patient. The needle was broken and stuck inside of the wire, could not be removed. The guide wire was hard/unable to be withdrawn. To resolve the issue anew catheter was used. The catheter was not repaired and there was no leak. The patient's status was asked, but unknown.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, during insertion the guidewire was broken, became stuck and could not be removed from the catheter. The guidewire was provided with the catheter kit and a new kit was used to complete the procedure. There was no reported patient injury.
 
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Brand NameMAHURKAR
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
MDR Report Key8446455
MDR Text Key139669395
Report Number3009211636-2019-00066
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup,Followup
Report Date 06/27/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/22/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8813793009
Device Catalogue Number8813793009
Device Lot Number1711200106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/26/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/10/2019
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 03/22/2019 Patient Sequence Number: 1
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