MAUDE Adverse Event Report: COOK INC CHAIT PERCUTANEOUS CECOSTOMY CATHETER; KNT TUBES, GASTROINTESTINAL

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/23/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
The customer reported that the chait percutaneous cecostomy catheter is breaking at an unspecified time following implantation.The device reportedly broke at the junction of the catheter and the patient externalized portion of the hub.The broken catheter was explanted and replaced with a new device.The handling conditions and circumstances surrounding the event are not known.No further event or patient information was provided.The device was returned for evaluation.
Additional Manufacturer Narrative
A review of the device history record, complaint history, drawing, instructions for use, manufacturing instructions, quality control data, and a visual inspection was conducted during the investigation.One used, damaged catheter was returned with biomatter present.The catheter is fractured approximately 1 to 2mm from the junction with the trap door fitting.The fracture lines up with the distal end of the male post from the door when the door is closed.Device was otherwise intact with no additional damage to the catheter or trapdoor.The implant date of the complaint device was confirmed to be unknown.The instructions for use state that the catheter should be changed every 6 months to reduce the risk of catheter fracture in the patient.Depending on how long the device was used inside the patient, it is possible that the root cause of this failure could have been related to product maintenance.It is also possible that the fracture could have occurred from excessive bending or tensile force on the catheter around the male post from the door while the door was closed.There is no evidence to suggests that the device was not manufactured to specification.However, with the limited information provided at this time, we are not able to determine with certainty what led to the failure mode.Quality control documentation confirms the correct type and size of catheter tubing and that the overall surface is free of excessive dents, bumps, and debris.Instructions for use describe the proper catheter placement, usage, and maintenance techniques, as well as appropriate warnings and precautions for this device.The instructions for use contain the following the precaution: "the catheter should be changed every 6 months to reduce the risk of catheter fracture in the patient." additionally, the patient guide includes sections on proper usage, maintenance and troubleshooting.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product shows no nonconforming events that would contribute to this failure mode.There were no other reported complaints for this lot number.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is warranted.Monitoring will continue to be performed for similar complaints.

• Brand Name: CHAIT PERCUTANEOUS CECOSTOMY CATHETER
• Common Device Name: KNT TUBES, GASTROINTESTINAL
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6430957
• Report Number: 1820334-2017-00546
• Device Sequence Number: 16157836
• Product Code: KNT
• UDI-Device Identifier: 00827002126855
• UDI-Public: (01)00827002126855(17)191117(10)7387787
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K982500
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Medical Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: TDCS-100-L
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 02/23/2017
• Supplement Date Received by Manufacturer: 09/19/2017
• Initial Report FDA Received Date: 03/24/2017
• Supplement Report FDA Received Date: 10/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention