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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 8831661001
Device Problems Material Frayed (1262); Difficult to Remove (1528)
Patient Problem Hematoma (1884)
Event Date 01/15/2021
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
According to the reporter, after the catheter was inserted into the femoral vein for urgent hemodialysis connection, the catheter im plantation was completed, however, the physician was unable to advance the guide wire from the dialysis catheter inserted into the lumen of the venous vessel. The guidewire was stuck in the venous with the catheter when it was being removed; it was blocked, and the removal was not possible. After several attempts to eject the guide wire, it could not be removed. The doctor had to pull out the newly inserted catheter along with the guide wire. After removing the guide wire, significant damage (frayed) in one place was seen. All guide wire was removed from the patient vessel. It was not necessary to use x-ray or other procedure to check for retained pieces. They used strength or excessive force to take out/remove the guide wire but no tools used. The issue/damage with the guide wire was not noticed in the packaging. There was no resistance used when inserting the guidewire. The guide wire used was the one included in the kit. There was no damage to the device's box or packaging. The product/kit was still sealed upon receipt of the customer. Nothing unusual observed on the device prior to use. Flushing was done without problem prior to use. All the catheter kit was utilized with the device. No other defects/damages found on the product. There was no problem with the catheter's dimension and there was no occlusion. The catheter was not repaired, no leak, no tego utilized and no luer adapter issue. No cleaning agent used on the device. There was no blood loss and blood transfusion was not required. Big hematoma was noted in the place of catheter insertion and it was due to the event. Nothing special was needed and the hematoma has resolved by itself. There was no extended patient hospitalization. No other interventions or treatments provided to the patient as a result of this event. The product was replaced with the second catheter from the box with the same lot on the same day to resolve the issue and the new device was used successfully. The procedure was completed. The patient was stable.
 
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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
CS 20101
Manufacturer (Section G)
COVIDIEN MFG SOLUTIONS S.A.
edificio b20, calle #2
alajuela 20101
CS 20101
Manufacturer Contact
avi kluger
5920 longbow drive
boulder, CO 80301
3035306582
MDR Report Key11342112
MDR Text Key232386175
Report Number3009211636-2021-00045
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodePL
PMA/PMN Number
K943349
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 05/27/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number8831661001
Device Catalogue Number8831661001
Device Lot Number2009200112
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 Received05/05/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/18/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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