MAUDE Adverse Event Report: COOK MEDICAL WAYNE PNEUMOTHORAX TRAY, COOK MEDICAL

Device Problems Improper or Incorrect Procedure or Method (2017); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problems Chest Pain (1776); Dyspnea (1816); Pneumothorax (2012)

Event Type  Injury  

Event Description

A 14.0 fr catheter (wayne pneumothorax tray, cook medical, bloomington, indiana, usa) was placed for treatment of a pneumothorax.During the pt's hospital course, he continued to complain of dyspnea and developed chest pain, and had persistent pneumothorax on subsequent chest imaging, including chest ct which confirmed the catheter to be in the pleural space.Manipulation of the catheter including gradual withdrawal of the tube did not resolve the pt's complaints.Ultimately, the clinical team recognized that the catheter had not been removed from the 14.0fr catheter following initial insertion.The 14.0fr catheter was removed and a larger thoracostomy tube was placed.The error was reported through the institution's electronic safety reporting system.Human error played a role in the occurrence and duration of this error, though several features of the product design create talent risks for the error observed in this case.The catheter obturator used to straighten the pigtail tip of the catheter during insertion has a luer lock connector that is compatible with drainage tubing, enabling an operator to connect the two, rather than removing the catheter obturator prior to drainage tube connection.This luer lock connector on the obturator serves no essential purpose in the kit and could be eliminated, preventing the error.The tissue dilator has an identical luer lock connector, again a potential source of error with no necessity for the kit.The luer lock adapters described above may have once had an intended purpose by the mfr for some rare case, but flexibility of a kit should be weighed against safety and risk.Flexibility creates opportunities to make incorrect choices, and may not be justified by rare use cases.The mfr's insertion video does not show or suggest any need/use for the luer lock adapter that facilitated the error (http://www.Cookmedical.Com/products/cc_utpt_webds/).The catheter obturator is also inconspicuous when in place within the pigtail catheter, as it is hidden completely within the catheter.This facilitates operator error, as an operator may not notice that the catheter obturator has not been removed.Both the dilator and the catheter obturator have a narrow internal channel, necessary for passage of the seldinger wire, but not large enough for these to function effectively for drainage of pleural air or fluid.Both the catheter obturator and the tissue dilator are colored an inconspicuous grey color, attention could be called to these devices by coloring these red (or perhaps another color, to avoid problems for operators with red-green color blindness) to indicate that they should be removed or discarded.A warning label or more explicit instructions could be provided to prevent the error from occurring, by specifically calling operators' attention to this possible error.A sterile copy of the instructions or figures could be included in the kit, currently, the instructions are affixed to the non-sterile exterior of the kit or available online (https://www.Cookmedical.Com/data/ifu_pdf/c_t_waynemod_rev4.Pdf).The device could be made more radiographically apparent, to increase the likelihood that it would be recognized by a radiologist or clinician if advertently left in place.

• Brand Name: WAYNE PNEUMOTHORAX TRAY, COOK MEDICAL
• Type of Device: WAYNE PNEUMOTHORAX TRAY, COOK MEDICAL
• Manufacturer (Section D): COOK MEDICAL; bloomington IN
• MDR Report Key: 7494104
• MDR Text Key: 107828782
• Report Number: MW5077049
• Device Sequence Number: 1
• Product Code: DQR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other