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

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.

• 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 Key: 4146751
• MDR Text Key: 4928083
• Report Number: 1820334-2014-00462
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• 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

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2016
• Device Catalogue Number: C-PCS-PHH
• Device Lot Number: 4085447
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/27/2014
• Device Age: 7 MO
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR
• Patient Weight: 70