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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COOK, INC. PERICARDIOCENTESIS CATHETER SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC

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COOK, INC. PERICARDIOCENTESIS CATHETER SET; DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC Back to Search Results
Catalog Number C-PCS-PHH
Device Problem Material Separation (1562)
Patient Problem Foreign body, removal of (2365)
Event Date 08/27/2014
Event Type  Injury  
Event Description
During a drainage of pleural effusion on a (b)(6) female patient with pre-existing septic shock and renal failure; two catheters were inserted into the pt (one on each side of patients' chest) at hospital 1.Patient was later transferred to another facility (hospital 2) due to monetary issue.When removing the catheter, the left one fractured and the tip was retained in patient's chest, while the right one was partially fractured although it was successfully removed.Additional info provided on 09/03/2014 stated that the fractured device was removed by a cut-down procedure on (b)(6) 2014.It was further stated that the tip was left in the subcutaneous tissue and not the pleural cavity.
 
Manufacturer Narrative
(b)(4).Per info supplied by the customer, no product will be returned.However, the customer did provide images for review.The catheter tip on one catheter was completely separated and appeared to have a stretched jagged edges.The other catheter was partially separated proximal of the fourth sideport.Quality control confirms overall surface of catheters in clean, smooth and free of damage.During investigation, a review of complaint history, review of device history record, review of ifu and a review of qc was performed.This product is shipped with instructions for use which states warnings, precautions and instructions for use.Based on the images provided, it is possible that upon removal the catheter was exposed to forces beyond its design.The root cause was determined to be product use/handling related as the product received excessive pressure.Quality engineering risk assessment was used to assess the risk of this complaint.Per the conclusion further risk reduction is recommended, but not required.The residual risk has been deemed acceptable, due in part to low occurrence and high detection.In a limited number of cases users may exert excessive force when removing the device (possibly due to patient anatomy), which occurred in this case.The appropriate internal personnel are notified as a result of the complaint.The benefits of the device outweigh the associated risk.We will continue to monitor for similar complaints.
 
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Brand Name
PERICARDIOCENTESIS CATHETER SET
Type of Device
DQO CATHETER, INTRAVASCULAR, DIAGNOSTIC
Manufacturer (Section D)
COOK, INC.
bloomington IN 47404
Manufacturer Contact
rita harden, director
750 daniels way
bloomington, IN 47404
8123392235
MDR Report Key4146751
MDR Text Key4928083
Report Number1820334-2014-00462
Device Sequence Number1
Product Code DQO
Combination Product (y/n)N
Reporter Country CodeSN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 08/27/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date02/01/2016
Device Catalogue NumberC-PCS-PHH
Device Lot Number4085447
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Distributor Facility Aware Date08/27/2014
Device Age7 MO
Event Location Hospital
Initial Date Manufacturer Received 08/28/2014
Initial Date FDA Received09/23/2014
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/01/2013
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age79 YR
Patient Weight70
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