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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK MEDICAL COOK CENTESIS CATHETER NEEDLE; 5F 10CM CENTESIS CATHETER
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COOK MEDICAL COOK CENTESIS CATHETER NEEDLE; 5F 10CM CENTESIS CATHETER Back to Search Results
Model Number DTVN-5.0-19-10. 0-YU
Device Problem Break (1069)
Patient Problem Foreign Body In Patient (2687)
Event Date 09/16/2016
Event Type  Injury  
Event Description
This pt presented for drainage of his chronic and recurrent ascites.Under ultrasound guidance a 5f 10 cm centesis needle was inserted into the peritoneum and 8000 ml of yellow colored fluid was removed.Upon removal of the catheter, the tip was noted to be fracture with a portion missing.Focal sonographic imaging demonstrated the fractured tip adherent to the abdominal wall.Multiple attempts to capture the catheter using forceps and ultrasound guidance were unsuccessful.The pt, who was an outpatient underwent a ct abdomen to identify location of catheter tip, then was admitted.As the risks out weighted the benefits of surgical removal, the pt was discharged.One week later, he was readmitted as an out patient, and the fragment tip was removed via fluoroscopy.
 
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Brand Name
COOK CENTESIS CATHETER NEEDLE
Type of Device
5F 10CM CENTESIS CATHETER
Manufacturer (Section D)
COOK MEDICAL
750 daniels way
bloomington IN 47404
MDR Report Key5982949
MDR Text Key55913606
Report NumberMW5065055
Device Sequence Number1
Product Code DQR
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 10/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/26/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberDTVN-5.0-19-10. 0-YU
Device Catalogue NumberG09490
Device Lot Number692075,OR 7137282, OR 7031680
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age53 YR
Patient Weight79
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