MAUDE Adverse Event Report: COOK MEDICAL MALECOT CATHETER

Model Number SILICONE 12 FR

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/04/2014

Event Type  Injury  

Event Description

Pt is a (b)(6) year old male with a history of recent bladder neck reconstruction on (b)(6) 2014.He was admitted on (b)(6) 2014 for endoscopic eval.He had some leakage from his midline incision.He was taken to the operating room on (b)(6) 2014 for removal of all tubes and drains that were placed on (b)(6) 2014.When the 12 french malecot catheter was removed the tip was missing.A cystoscopy was done and the missing tip was not in the bladder.A small incision was made and an exploratory lap was preformed to look for the tip between the bladder and abdominal wall.It could not be located.An x-ray was also taken which did not show the missing tip.It is not radiopaque.

• Brand Name: MALECOT CATHETER
• Type of Device: MALECOT CATHETER
• Manufacturer (Section D): COOK MEDICAL; bloomington IN
• MDR Report Key: 4034917
• MDR Text Key: 20657030
• Report Number: 4034917
• Device Sequence Number: 1
• Product Code: FEW
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/12/2014,08/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: SILICONE 12 FR
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/12/2014
• Distributor Facility Aware Date: 08/04/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/12/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 4 YR